what is clinical research study

Masks Strongly Recommended but Not Required in Maryland

Respiratory viruses continue to circulate in Maryland, so masking remains strongly recommended when you visit Johns Hopkins Medicine clinical locations in Maryland. To protect your loved one, please do not visit if you are sick or have a COVID-19 positive test result. Get more resources on masking and COVID-19 precautions .

• Vaccines  
• Masking Guidelines
• Visitor Guidelines  

Understanding Clinical Trials

Clinical research: what is it.

Your doctor may have said that you are eligible for a clinical trial, or you may have seen an ad for a clinical research study. What is clinical research, and is it right for you?

Clinical research is the comprehensive study of the safety and effectiveness of the most promising advances in patient care. Clinical research is different than laboratory research. It involves people who volunteer to help us better understand medicine and health. Lab research generally does not involve people — although it helps us learn which new ideas may help people.

Every drug, device, tool, diagnostic test, technique and technology used in medicine today was once tested in volunteers who took part in clinical research studies.

At Johns Hopkins Medicine, we believe that clinical research is key to improve care for people in our community and around the world. Once you understand more about clinical research, you may appreciate why it’s important to participate — for yourself and the community.

What Are the Types of Clinical Research?

There are two main kinds of clinical research:

Observational Studies

Observational studies are studies that aim to identify and analyze patterns in medical data or in biological samples, such as tissue or blood provided by study participants.

Clinical Trials

Clinical trials, which are also called interventional studies, test the safety and effectiveness of medical interventions — such as medications, procedures and tools — in living people.

Clinical research studies need people of every age, health status, race, gender, ethnicity and cultural background to participate. This will increase the chances that scientists and clinicians will develop treatments and procedures that are likely to be safe and work well in all people. Potential volunteers are carefully screened to ensure that they meet all of the requirements for any study before they begin. Most of the reasons people are not included in studies is because of concerns about safety.

Both healthy people and those with diagnosed medical conditions can take part in clinical research. Participation is always completely voluntary, and participants can leave a study at any time for any reason.

“The only way medical advancements can be made is if people volunteer to participate in clinical research. The research participant is just as necessary as the researcher in this partnership to advance health care.” Liz Martinez, Johns Hopkins Medicine Research Participant Advocate

Types of Research Studies

Within the two main kinds of clinical research, there are many types of studies. They vary based on the study goals, participants and other factors.

Biospecimen studies

Healthy volunteer studies.

 Goals of Clinical Trials

Because every clinical trial is designed to answer one or more medical questions, different trials have different goals. Those goals include:

Treatment trials

Prevention trials, screening trials, phases of a clinical trial.

In general, a new drug needs to go through a series of four types of clinical trials. This helps researchers show that the medication is safe and effective. As a study moves through each phase, researchers learn more about a medication, including its risks and benefits.

Is the medication safe and what is the right dose?   Phase one trials involve small numbers of participants, often normal volunteers.

Does the new medication work and what are the side effects?   Phase two trials test the treatment or procedure on a larger number of participants. These participants usually have the condition or disease that the treatment is intended to remedy.

Is the new medication more effective than existing treatments?  Phase three trials have even more people enrolled. Some may get a placebo (a substance that has no medical effect) or an already approved treatment, so that the new medication can be compared to that treatment.

Is the new medication effective and safe over the long term?   Phase four happens after the treatment or procedure has been approved. Information about patients who are receiving the treatment is gathered and studied to see if any new information is seen when given to a large number of patients.

“Johns Hopkins has a comprehensive system overseeing research that is audited by the FDA and the Association for Accreditation of Human Research Protection Programs to make certain all research participants voluntarily agreed to join a study and their safety was maximized.” Gail Daumit, M.D., M.H.S., Vice Dean for Clinical Investigation, Johns Hopkins University School of Medicine

Is It Safe to Participate in Clinical Research?

There are several steps in place to protect volunteers who take part in clinical research studies. Clinical Research is regulated by the federal government. In addition, the institutional review board (IRB) and Human Subjects Research Protection Program at each study location have many safeguards built in to each study to protect the safety and privacy of participants.

Clinical researchers are required by law to follow the safety rules outlined by each study's protocol. A protocol is a detailed plan of what researchers will do in during the study.

In the U.S., every study site's IRB — which is made up of both medical experts and members of the general public — must approve all clinical research. IRB members also review plans for all clinical studies. And, they make sure that research participants are protected from as much risk as possible.

Earning Your Trust

This was not always the case. Many people of color are wary of joining clinical research because of previous poor treatment of underrepresented minorities throughout the U.S. This includes medical research performed on enslaved people without their consent, or not giving treatment to Black men who participated in the Tuskegee Study of Untreated Syphilis in the Negro Male. Since the 1970s, numerous regulations have been in place to protect the rights of study participants.

Many clinical research studies are also supervised by a data and safety monitoring committee. This is a group made up of experts in the area being studied. These biomedical professionals regularly monitor clinical studies as they progress. If they discover or suspect any problems with a study, they immediately stop the trial. In addition, Johns Hopkins Medicine’s Research Participant Advocacy Group focuses on improving the experience of people who participate in clinical research.

Clinical research participants with concerns about anything related to the study they are taking part in should contact Johns Hopkins Medicine’s IRB or our Research Participant Advocacy Group .

Learn More About Clinical Research at Johns Hopkins Medicine

For information about clinical trial opportunities at Johns Hopkins Medicine, visit our trials site.

Video Clinical Research for a Healthier Tomorrow: A Family Shares Their Story

Clinical Research for a Healthier Tomorrow: A Family Shares Their Story

About Clinical Trials

What is a clinical trial.

Clinical trials look at new ways to prevent, detect, or treat disease. The goal of clinical trials is to determine if a new test or treatment works and is safe. 

The idea for a clinical trial —also known as a clinical research study —often originates in the laboratory. After researchers test new therapies or procedures in the laboratory and in animal studies, the most promising experimental treatments are moved into clinical trials, which are conducted in phases. During a trial, more information is gained about an experimental treatment, its risks, and its effectiveness.

Types of Clinical Trials

• Natural history studies provide valuable information about how disease and health progress.
• Prevention trials look for better ways to prevent a disease in people who have never had the disease or to prevent the disease from returning. Better approaches may include medicines, vaccines, or lifestyle changes, among other things.
• Screening trials test the best way to detect certain diseases or health conditions.
• Diagnostic trials determine better tests or procedures for diagnosing a particular disease or condition.
• Treatment trials test new treatments, new combinations of drugs, or new approaches to surgery or radiation therapy.
• Quality of life trials (or supportive care trials) explore and measure ways to improve the comfort and quality of life of people with a chronic illness.

Clinical Trial Phases

Clinical trials are conducted in phases. Each phase has a different purpose and helps researchers answer different questions.

• Phase I trials: Researchers test an experimental drug or treatment in a small group of people (20–80) for the first time. The purpose is to evaluate its safety and identify side effects.
• Phase II trials: The experimental drug or treatment is administered to a larger group of people (100–300) to determine its effectiveness and to further evaluate its safety.
• Phase III trials: The experimental drug or treatment is administered to large groups of people (1,000–3,000) to confirm its effectiveness, monitor side effects, compare it with standard or equivalent treatments, and collect information that will allow the experimental drug or treatment to be used safely.
• Phase IV trials: After a drug is approved by the FDA and made available to the public, researchers track its safety, seeking more information about a drug or treatment’s risks, benefits, and optimal use.

For more information about clinical trials, see the webpage at National Institute of Health.

• U.S. Department of Health & Human Services

• Virtual Tour
• Staff Directory
• En Español

You are here

Science, health, and public trust.

October 18, 2016

Understanding Clinical Studies

• Printable version

Part of the challenge of explaining clinical research to the public is describing the important points of a study without going into a detailed account of the study’s design. There are many different kinds of clinical studies, each with their own strengths and weaknesses, and no real shorthand way to explain them. Researchers sometimes don’t explicitly state the kind of study they’re talking about. To them, it’s obvious; they’ve been living and breathing this research for years, sometimes decades. But study design can often be difficult even for seasoned health and science communicators to understand.

The gold standard for proving that a treatment or medical approach works is a well-designed randomized controlled trial. This type of study allows researchers to test medical interventions by randomly assigning participants to treatment or control groups. The results can help determine if there’s a cause-and-effect relationship between the treatment and outcomes. But clinical researchers can’t always use this approach. For example, scientists can’t ethically study risky behaviors by asking people to start smoking or eating an unhealthy diet. And they can’t study the health effects of the environment by assigning people to live in different places.

Thus, researchers must often turn to some type of observational study, in which a population’s health or behaviors are observed and analyzed. These studies can’t prove cause and effect, but they can be useful for finding associations. Observational studies can also help researchers understand a situation and come up with hypotheses that can then be put to the test in clinical trials. These types of studies have been essential to understanding the genetic, infectious, environmental, and behavioral causes of disease.

We’ve developed a one-page guide to clarify the different kinds of clinical studies researchers use, to explain why researchers might use them, and to touch a little on each type’s strengths and weaknesses. We hope it can serve as a useful resource to explain clinical research, whether you’re describing the results of a study to the public or the design of a trial to a potential participant. Please take a look and share your thoughts with us by sending an email to [email protected] .

Connect with Us

• More Social Media from NIH

• Fact sheets
• Facts in pictures

Publications

• Questions and answers
• Tools and toolkits
• Endometriosis
• Excessive heat
• Mental disorders
• Polycystic ovary syndrome
• All countries
• Eastern Mediterranean
• South-East Asia
• Western Pacific
• Data by country
• Country presence 
• Country strengthening 
• Country cooperation strategies 
• News releases

Feature stories

• Press conferences
• Commentaries
• Photo library
• Afghanistan
• Cholera 
• Coronavirus disease (COVID-19)
• Greater Horn of Africa
• Israel and occupied Palestinian territory
• Disease Outbreak News
• Situation reports
• Weekly Epidemiological Record
• Surveillance
• Health emergency appeal
• International Health Regulations
• Independent Oversight and Advisory Committee
• Classifications
• Data collections
• Global Health Observatory
• Global Health Estimates
• Mortality Database
• Sustainable Development Goals
• Health Inequality Monitor
• Global Progress
• World Health Statistics
• Partnerships
• Committees and advisory groups
• Collaborating centres
• Technical teams
• Organizational structure
• Initiatives
• General Programme of Work
• WHO Academy
• Investment in WHO
• WHO Foundation
• External audit
• Financial statements
• Internal audit and investigations 
• Programme Budget
• Results reports
• Governing bodies
• World Health Assembly
• Executive Board
• Member States Portal
• Health topics /

Clinical trials

Clinical trials are a type of research that studies new tests and treatments and evaluates their effects on human health outcomes. People volunteer to take part in clinical trials to test medical interventions including drugs, cells and other biological products, surgical procedures, radiological procedures, devices, behavioural treatments and preventive care.

Clinical trials are carefully designed, reviewed and completed, and need to be approved before they can start. People of all ages can take part in clinical trials, including children.

There are 4 phases of biomedical clinical trials:

• Phase I studies usually test new drugs for the first time in a small group of people to evaluate a safe dosage range and identify side effects.
• Phase II studies test treatments that have been found to be safe in phase I but now need a larger group of human subjects to monitor for any adverse effects.
• Phase III studies are conducted on larger populations and in different regions and countries, and are often the step right before a new treatment is approved.
• Phase IV studies take place after country approval and there is a need for further testing in a wide population over a longer timeframe.

Clinical trials usually involve participants from more than one medical or research institution, and often more than one country. As each country has its own requirements for clinical trials research it is possible that single trials could be included on more than one registry, and hence appear on more than one registry database. However, data on various clinical trial registries varies.

WHO’s International Clinical Trials Registry Platform (ICTRP) links clinical trials registers globally in order to ensure a single point of access and the unambiguous identification of trials with a view to enhancing access to information by patients, families, patient groups and others.

The ICTRP is a global initiative that aims to make information about all clinical trials involving humans publicly available. It also aims to:

• improve the comprehensiveness, completeness and accuracy of registered clinical trial data;
• communicate and raise awareness of the need to register clinical trials;
• ensure the accessibility of registered data;
• build capacity for clinical trial registration;
• encourage the utilization of registered data; and
• ensure the sustainability of the ICTRP.
• What is a clinical trial
• FAQ about the Universal Trial Numbers (UTN)
• WHA58.22 Ministerial Summit on Health Research
• WHA75.8 Strengthening clinical trials to provide high-quality evidence on health interventions and to improve research quality and coordination
• International Clinical Trials Registry Platform team

WHO consults on action plan for sustainable clinical research infrastructure

New member of the Primary Registry Network: International Traditional Medicine Clinical Trial Registry (ITMCTR)

New WHA resolution on clinical trials

New member of the Primary Registry Network: Lebanese Clinical Trials Registry (LBCTR)

International Standards for Clinical Trial Registries

Operational guidance: information needed to support clinical trials of herbal products

Reporting the findings of clinical trials: a discussion paper

When researchers embark on a clinical trial, they make a commitment to con-duct the trial and to report the findings in accordance with basic ethical...

Solidarity Trial Vaccines (STV) presentation

 This is a global presentation of the STV: its key features, aims, methods, procedures and outputs.Presentation available in french.  

Solidarity Trial Vaccines (STV) flipbook

This flipbook is for staff of the Solidarity Trial Vaccines (STV). It is a resource that can be used to guide conversation and information exchange between...

Good Participatory Practice (GPP) for COVID-19 clinical trials: A toolbox

This document draws on the World Health Organization’s Good Participatory Practice Guidelines for Emerging Pathogens (GPP-EP) (2016) which were adapted...

International Clinical Trials Registry Platform - A4 flyer

GermanKoreanPersianThai

Mothers in Malawi value the first malaria vaccine

WHO advises that ivermectin only be used to treat COVID-19 within clinical trials

Related health topics

Global health ethics

Patient safety

What Are Clinical Trials?

Talk with your doctor about clinical trials when you discuss treatment options. 

Clinical trials are research studies that test how well new medical approaches work in people. 

What is the purpose of a clinical trial? 

Clinical trials test new ways to find, prevent, and treat cancer. They also help doctors improve the quality of life for people with cancer by testing ways to manage the side effects of cancer and its treatment. 

Why are clinical trials important?

Today, people are living longer lives thanks to results of past cancer clinical trials. When you take part in a clinical trial, you add to our knowledge about cancer and help improve cancer care for people in the future.

People join clinical trials for many reasons. People living with cancer often join trials because they want to help future patients. People with certain risk factors want to help doctors learn how to prevent cancer. Healthy volunteers want to help doctors learn how to find cancer early. 

People with cancer and healthy volunteers join trials to play a role in cancer research and move science forward to help others.  

What are the types of clinical trials?

"I feel that as an African American we do not participate in programs that could BE and sometimes ARE beneficial to us. I hope by my participation this will encourage others African American women to be more open." —Marsha Dukes, NCI clinical trial participant

There are several types of cancer clinical trials. Each type of trial is designed to answer different research questions and will help researchers learn things that can help people in the future.

Treatment Trials

Most cancer clinical trials are treatment studies that involve people who have cancer. These trials test new treatments or new ways of using existing treatments, including new:

• approaches to surgery or radiation therapy
• combinations of treatments

As researchers learn more about the genetic changes that lead to cancer, doctors are testing treatments that target these specific changes. So in some treatment trials, your tumor may be tested to see if treatments targeting specific genetic changes might work better than standard treatments. 

Treatment trials are designed to answers questions such as:

• What is a safe dose of the treatment under study?
• How should the treatment be given?
• Does the treatment help people with cancer live longer than current treatment?
• Can the study treatment shrink tumors or slow their growth and spread?
• What are the treatment's side effects?
• Does the study treatment allow for a better quality of life with fewer side effects?
• Does the treatment help delay the return of the cancer?

Participate in Cancer Prevention Studies

Learn about cancer prevention studies and how to participate.

Prevention Trials

Prevention trials are studies that look at ways to prevent cancer.

In most prevention trials, the people who take part do not have cancer but are at high risk for developing it. Or they have had cancer and are at high risk for developing a new cancer.

There are two kinds of prevention trials, action studies and agent studies. In action studies, you are asked to do something, such as exercise or follow a special diet. In agent studies, you are asked to take something, such as a drug or vitamin. Learn about participating in prevention studies .

Researchers who conduct these studies want to know:

• How safe is the drug or activity?
• Does the new approach reduce the chance that someone will get cancer?

Cancer Screening Studies

Learn about joining a screening trial to help find cancer early.

Screening Trials

The goal of cancer screening trials is to test ways to find cancer before it causes symptoms, when it may be easier to treat.

An effective screening test will reduce the number of people who die from the cancer that is being screened for. Learn about joining a cancer screening study . 

But screening tests can have harms, which include bleeding or other physical damage. Other possible harms include a result that shows you might have cancer when you don’t. When this happens, it may lead to unnecessary tests and procedures. On the other hand, the results may show no signs of cancer when you have it. And sometimes screening can find cancers that would not have harmed you during your lifetime.

Researchers who conduct cancer screening studies want to know:

• Does finding disease earlier, before people have any symptoms, save lives?
• Is one screening test better than another?
• Do the benefits of the screening test outweigh the harms?

Supportive Care/Palliative Care Trials

These trials look at ways to improve the quality of life of people with cancer, especially those who have side effects from cancer and its treatment.

They might test drugs, such as those that help with depression or nausea. Or they might test activities, such as attending support groups, exercising, or talking with a counselor.

Some of these trials test ways to help families and caregivers cope with their own needs, as well as those of the person with cancer.

• How does cancer and its treatment affect patients and their loved ones?
• What can improve the comfort and quality of life of people who have cancer?

An official website of the United States government

The .gov means it’s official. Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

The site is secure. The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

• Publications
• Account settings

Preview improvements coming to the PMC website in October 2024. Learn More or Try it out now .

• Advanced Search
• Journal List
• Pediatr Investig
• v.3(4); 2019 Dec

Clinical research study designs: The essentials

Ambika g. chidambaram.

1 Children's Hospital of Philadelphia, Philadelphia Pennsylvania, USA

Maureen Josephson

In clinical research, our aim is to design a study which would be able to derive a valid and meaningful scientific conclusion using appropriate statistical methods. The conclusions derived from a research study can either improve health care or result in inadvertent harm to patients. Hence, this requires a well‐designed clinical research study that rests on a strong foundation of a detailed methodology and governed by ethical clinical principles. The purpose of this review is to provide the readers an overview of the basic study designs and its applicability in clinical research.

Introduction

In clinical research, our aim is to design a study, which would be able to derive a valid and meaningful scientific conclusion using appropriate statistical methods that can be translated to the “real world” setting. 1 Before choosing a study design, one must establish aims and objectives of the study, and choose an appropriate target population that is most representative of the population being studied. The conclusions derived from a research study can either improve health care or result in inadvertent harm to patients. Hence, this requires a well‐designed clinical research study that rests on a strong foundation of a detailed methodology and is governed by ethical principles. 2

From an epidemiological standpoint, there are two major types of clinical study designs, observational and experimental. 3 Observational studies are hypothesis‐generating studies, and they can be further divided into descriptive and analytic. Descriptive observational studies provide a description of the exposure and/or the outcome, and analytic observational studies provide a measurement of the association between the exposure and the outcome. Experimental studies, on the other hand, are hypothesis testing studies. It involves an intervention that tests the association between the exposure and outcome. Each study design is different, and so it would be important to choose a design that would most appropriately answer the question in mind and provide the most valuable information. We will be reviewing each study design in detail (Figure  1 ).

Overview of clinical research study designs

Observational study designs

Observational studies ask the following questions: what, who, where and when. There are many study designs that fall under the umbrella of descriptive study designs, and they include, case reports, case series, ecologic study, cross‐sectional study, cohort study and case‐control study (Figure  2 ).

Classification of observational study designs

Case reports and case series

Every now and then during clinical practice, we come across a case that is atypical or ‘out of the norm’ type of clinical presentation. This atypical presentation is usually described as case reports which provides a detailed and comprehensive description of the case. 4 It is one of the earliest forms of research and provides an opportunity for the investigator to describe the observations that make a case unique. There are no inferences obtained and therefore cannot be generalized to the population which is a limitation. Most often than not, a series of case reports make a case series which is an atypical presentation found in a group of patients. This in turn poses the question for a new disease entity and further queries the investigator to look into mechanistic investigative opportunities to further explore. However, in a case series, the cases are not compared to subjects without the manifestations and therefore it cannot determine which factors in the description are unique to the new disease entity.

Ecologic study

Ecological studies are observational studies that provide a description of population group characteristics. That is, it describes characteristics to all individuals within a group. For example, Prentice et al 5 measured incidence of breast cancer and per capita intake of dietary fat, and found a correlation that higher per capita intake of dietary fat was associated with an increased incidence of breast cancer. But the study does not conclude specifically which subjects with breast cancer had a higher dietary intake of fat. Thus, one of the limitations with ecologic study designs is that the characteristics are attributed to the whole group and so the individual characteristics are unknown.

Cross‐sectional study

Cross‐sectional studies are study designs used to evaluate an association between an exposure and outcome at the same time. It can be classified under either descriptive or analytic, and therefore depends on the question being answered by the investigator. Since, cross‐sectional studies are designed to collect information at the same point of time, this provides an opportunity to measure prevalence of the exposure or the outcome. For example, a cross‐sectional study design was adopted to estimate the global need for palliative care for children based on representative sample of countries from all regions of the world and all World Bank income groups. 6 The limitation of cross‐sectional study design is that temporal association cannot be established as the information is collected at the same point of time. If a study involves a questionnaire, then the investigator can ask questions to onset of symptoms or risk factors in relation to onset of disease. This would help in obtaining a temporal sequence between the exposure and outcome. 7

Case‐control study

Case‐control studies are study designs that compare two groups, such as the subjects with disease (cases) to the subjects without disease (controls), and to look for differences in risk factors. 8 This study is used to study risk factors or etiologies for a disease, especially if the disease is rare. Thus, case‐control studies can also be hypothesis testing studies and therefore can suggest a causal relationship but cannot prove. It is less expensive and less time‐consuming than cohort studies (described in section “Cohort study”). An example of a case‐control study was performed in Pakistan evaluating the risk factors for neonatal tetanus. They retrospectively reviewed a defined cohort for cases with and without neonatal tetanus. 9 They found a strong association of the application of ghee (clarified butter) as a risk factor for neonatal tetanus. Although this suggests a causal relationship, cause cannot be proven by this methodology (Figure  3 ).

Case‐control study design

One of the limitations of case‐control studies is that they cannot estimate prevalence of a disease accurately as a proportion of cases and controls are studied at a time. Case‐control studies are also prone to biases such as recall bias, as the subjects are providing information based on their memory. Hence, the subjects with disease are likely to remember the presence of risk factors compared to the subjects without disease.

One of the aspects that is often overlooked is the selection of cases and controls. It is important to select the cases and controls appropriately to obtain a meaningful and scientifically sound conclusion and this can be achieved by implementing matching. Matching is defined by Gordis et al as ‘the process of selecting the controls so that they are similar to the cases in certain characteristics such as age, race, sex, socioeconomic status and occupation’ 7 This would help identify risk factors or probable etiologies that are not due to differences between the cases and controls.

Cohort study

Cohort studies are study designs that compare two groups, such as the subjects with exposure/risk factor to the subjects without exposure/risk factor, for differences in incidence of outcome/disease. Most often, cohort study designs are used to study outcome(s) from a single exposure/risk factor. Thus, cohort studies can also be hypothesis testing studies and can infer and interpret a causal relationship between an exposure and a proposed outcome, but cannot establish it (Figure  4 ).

Cohort study design

Cohort studies can be classified as prospective and retrospective. 7 Prospective cohort studies follow subjects from presence of risk factors/exposure to development of disease/outcome. This could take up to years before development of disease/outcome, and therefore is time consuming and expensive. On the other hand, retrospective cohort studies identify a population with and without the risk factor/exposure based on past records and then assess if they had developed the disease/outcome at the time of study. Thus, the study design for prospective and retrospective cohort studies are similar as we are comparing populations with and without exposure/risk factor to development of outcome/disease.

Cohort studies are typically chosen as a study design when the suspected exposure is known and rare, and the incidence of disease/outcome in the exposure group is suspected to be high. The choice between prospective and retrospective cohort study design would depend on the accuracy and reliability of the past records regarding the exposure/risk factor.

Some of the biases observed with cohort studies include selection bias and information bias. Some individuals who have the exposure may refuse to participate in the study or would be lost to follow‐up, and in those instances, it becomes difficult to interpret the association between an exposure and outcome. Also, if the information is inaccurate when past records are used to evaluate for exposure status, then again, the association between the exposure and outcome becomes difficult to interpret.

Case‐control studies based within a defined cohort

Case‐control studies based within a defined cohort is a form of study design that combines some of the features of a cohort study design and a case‐control study design. When a defined cohort is embedded in a case‐control study design, all the baseline information collected before the onset of disease like interviews, surveys, blood or urine specimens, then the cohort is followed onset of disease. One of the advantages of following the above design is that it eliminates recall bias as the information regarding risk factors is collected before onset of disease. Case‐control studies based within a defined cohort can be further classified into two types: Nested case‐control study and Case‐cohort study.

Nested case‐control study

A nested case‐control study consists of defining a cohort with suspected risk factors and assigning a control within a cohort to the subject who develops the disease. 10 Over a period, cases and controls are identified and followed as per the investigator's protocol. Hence, the case and control are matched on calendar time and length of follow‐up. When this study design is implemented, it is possible for the control that was selected early in the study to develop the disease and become a case in the latter part of the study.

Case‐cohort Study

A case‐cohort study is similar to a nested case‐control study except that there is a defined sub‐cohort which forms the groups of individuals without the disease (control), and the cases are not matched on calendar time or length of follow‐up with the control. 11 With these modifications, it is possible to compare different disease groups with the same sub‐cohort group of controls and eliminates matching between the case and control. However, these differences will need to be accounted during analysis of results.

Experimental study design

The basic concept of experimental study design is to study the effect of an intervention. In this study design, the risk factor/exposure of interest/treatment is controlled by the investigator. Therefore, these are hypothesis testing studies and can provide the most convincing demonstration of evidence for causality. As a result, the design of the study requires meticulous planning and resources to provide an accurate result.

The experimental study design can be classified into 2 groups, that is, controlled (with comparison) and uncontrolled (without comparison). 1 In the group without controls, the outcome is directly attributed to the treatment received in one group. This fails to prove if the outcome was truly due to the intervention implemented or due to chance. This can be avoided if a controlled study design is chosen which includes a group that does not receive the intervention (control group) and a group that receives the intervention (intervention/experiment group), and therefore provide a more accurate and valid conclusion.

Experimental study designs can be divided into 3 broad categories: clinical trial, community trial, field trial. The specifics of each study design are explained below (Figure  5 ).

Experimental study designs

Clinical trial

Clinical trials are also known as therapeutic trials, which involve subjects with disease and are placed in different treatment groups. It is considered a gold standard approach for epidemiological research. One of the earliest clinical trial studies was performed by James Lind et al in 1747 on sailors with scurvy. 12 Lind divided twelve scorbutic sailors into six groups of two. Each group received the same diet, in addition to a quart of cider (group 1), twenty‐five drops of elixir of vitriol which is sulfuric acid (group 2), two spoonfuls of vinegar (group 3), half a pint of seawater (group 4), two oranges and one lemon (group 5), and a spicy paste plus a drink of barley water (group 6). The group who ate two oranges and one lemon had shown the most sudden and visible clinical effects and were taken back at the end of 6 days as being fit for duty. During Lind's time, this was not accepted but was shown to have similar results when repeated 47 years later in an entire fleet of ships. Based on the above results, in 1795 lemon juice was made a required part of the diet of sailors. Thus, clinical trials can be used to evaluate new therapies, such as new drug or new indication, new drug combination, new surgical procedure or device, new dosing schedule or mode of administration, or a new prevention therapy.

While designing a clinical trial, it is important to select the population that is best representative of the general population. Therefore, the results obtained from the study can be generalized to the population from which the sample population was selected. It is also as important to select appropriate endpoints while designing a trial. Endpoints need to be well‐defined, reproducible, clinically relevant and achievable. The types of endpoints include continuous, ordinal, rates and time‐to‐event, and it is typically classified as primary, secondary or tertiary. 2 An ideal endpoint is a purely clinical outcome, for example, cure/survival, and thus, the clinical trials will become very long and expensive trials. Therefore, surrogate endpoints are used that are biologically related to the ideal endpoint. Surrogate endpoints need to be reproducible, easily measured, related to the clinical outcome, affected by treatment and occurring earlier than clinical outcome. 2

Clinical trials are further divided into randomized clinical trial, non‐randomized clinical trial, cross‐over clinical trial and factorial clinical trial.

Randomized clinical trial

A randomized clinical trial is also known as parallel group randomized trials or randomized controlled trials. Randomized clinical trials involve randomizing subjects with similar characteristics to two groups (or multiple groups): the group that receives the intervention/experimental therapy and the other group that received the placebo (or standard of care). 13 This is typically performed by using a computer software, manually or by other methods. Hence, we can measure the outcomes and efficacy of the intervention/experimental therapy being studied without bias as subjects have been randomized to their respective groups with similar baseline characteristics. This type of study design is considered gold standard for epidemiological research. However, this study design is generally not applicable to rare and serious disease process as it would unethical to treat that group with a placebo. Please see section “Randomization” for detailed explanation regarding randomization and placebo.

Non‐randomized clinical trial

A non‐randomized clinical trial involves an approach to selecting controls without randomization. With this type of study design a pattern is usually adopted, such as, selection of subjects and controls on certain days of the week. Depending on the approach adopted, the selection of subjects becomes predictable and therefore, there is bias with regards to selection of subjects and controls that would question the validity of the results obtained.

Historically controlled studies can be considered as a subtype of non‐randomized clinical trial. In this study design subtype, the source of controls is usually adopted from the past, such as from medical records and published literature. 1 The advantages of this study design include being cost‐effective, time saving and easily accessible. However, since this design depends on already collected data from different sources, the information obtained may not be accurate, reliable, lack uniformity and/or completeness as well. Though historically controlled studies maybe easier to conduct, the disadvantages will need to be taken into account while designing a study.

Cross‐over clinical trial

In cross‐over clinical trial study design, there are two groups who undergoes the same intervention/experiment at different time periods of the study. That is, each group serves as a control while the other group is undergoing the intervention/experiment. 14 Depending on the intervention/experiment, a ‘washout’ period is recommended. This would help eliminate residuals effects of the intervention/experiment when the experiment group transitions to be the control group. Hence, the outcomes of the intervention/experiment will need to be reversible as this type of study design would not be possible if the subject is undergoing a surgical procedure.

Factorial trial

A factorial trial study design is adopted when the researcher wishes to test two different drugs with independent effects on the same population. Typically, the population is divided into 4 groups, the first with drug A, the second with drug B, the third with drug A and B, and the fourth with neither drug A nor drug B. The outcomes for drug A are compared to those on drug A, drug A and B and to those who were on drug B and neither drug A nor drug B. 15 The advantages of this study design that it saves time and helps to study two different drugs on the same study population at the same time. However, this study design would not be applicable if either of the drugs or interventions overlaps with each other on modes of action or effects, as the results obtained would not attribute to a particular drug or intervention.

Community trial

Community trials are also known as cluster‐randomized trials, involve groups of individuals with and without disease who are assigned to different intervention/experiment groups. Hence, groups of individuals from a certain area, such as a town or city, or a certain group such as school or college, will undergo the same intervention/experiment. 16 Hence, the results will be obtained at a larger scale; however, will not be able to account for inter‐individual and intra‐individual variability.

Field trial

Field trials are also known as preventive or prophylactic trials, and the subjects without the disease are placed in different preventive intervention groups. 16 One of the hypothetical examples for a field trial would be to randomly assign to groups of a healthy population and to provide an intervention to a group such as a vitamin and following through to measure certain outcomes. Hence, the subjects are monitored over a period of time for occurrence of a particular disease process.

Overview of methodologies used within a study design

Randomization.

Randomization is a well‐established methodology adopted in research to prevent bias due to subject selection, which may impact the result of the intervention/experiment being studied. It is one of the fundamental principles of an experimental study designs and ensures scientific validity. It provides a way to avoid predicting which subjects are assigned to a certain group and therefore, prevent bias on the final results due to subject selection. This also ensures comparability between groups as most baseline characteristics are similar prior to randomization and therefore helps to interpret the results regarding the intervention/experiment group without bias.

There are various ways to randomize and it can be as simple as a ‘flip of a coin’ to use computer software and statistical methods. To better describe randomization, there are three types of randomization: simple randomization, block randomization and stratified randomization.

Simple randomization

In simple randomization, the subjects are randomly allocated to experiment/intervention groups based on a constant probability. That is, if there are two groups A and B, the subject has a 0.5 probability of being allocated to either group. This can be performed in multiple ways, and one of which being as simple as a ‘flip of a coin’ to using random tables or numbers. 17 The advantage of using this methodology is that it eliminates selection bias. However, the disadvantage with this methodology is that an imbalance in the number allocated to each group as well as the prognostic factors between groups. Hence, it is more challenging in studies with a small sample size.

Block randomization

In block randomization, the subjects of similar characteristics are classified into blocks. The aim of block randomization is to balance the number of subjects allocated to each experiment/intervention group. For example, let's assume that there are four subjects in each block, and two of the four subjects in each block will be randomly allotted to each group. Therefore, there will be two subjects in one group and two subjects in the other group. 17 The disadvantage with this methodology is that there is still a component of predictability in the selection of subjects and the randomization of prognostic factors is not performed. However, it helps to control the balance between the experiment/intervention groups.

Stratified randomization

In stratified randomization, the subjects are defined based on certain strata, which are covariates. 18 For example, prognostic factors like age can be considered as a covariate, and then the specified population can be randomized within each age group related to an experiment/intervention group. The advantage with this methodology is that it enables comparability between experiment/intervention groups and thus makes result analysis more efficient. But, with this methodology the covariates will need to be measured and determined before the randomization process. The sample size will help determine the number of strata that would need to be chosen for a study.

Blinding is a methodology adopted in a study design to intentionally not provide information related to the allocation of the groups to the subject participants, investigators and/or data analysts. 19 The purpose of blinding is to decrease influence associated with the knowledge of being in a particular group on the study result. There are 3 forms of blinding: single‐blinded, double‐blinded and triple‐blinded. 1 In single‐blinded studies, otherwise called as open‐label studies, the subject participants are not revealed which group that they have been allocated to. However, the investigator and data analyst will be aware of the allocation of the groups. In double‐blinded studies, both the study participants and the investigator will be unaware of the group to which they were allocated to. Double‐blinded studies are typically used in clinical trials to test the safety and efficacy of the drugs. In triple‐blinded studies, the subject participants, investigators and data analysts will not be aware of the group allocation. Thus, triple‐blinded studies are more difficult and expensive to design but the results obtained will exclude confounding effects from knowledge of group allocation.

Blinding is especially important in studies where subjective response are considered as outcomes. This is because certain responses can be modified based on the knowledge of the experiment group that they are in. For example, a group allocated in the non‐intervention group may not feel better as they are not getting the treatment, or an investigator may pay more attention to the group receiving treatment, and thereby potentially affecting the final results. However, certain treatments cannot be blinded such as surgeries or if the treatment group requires an assessment of the effect of intervention such as quitting smoking.

Placebo is defined in the Merriam‐Webster dictionary as ‘an inert or innocuous substance used especially in controlled experiments testing the efficacy of another substance (such as drug)’. 20 A placebo is typically used in a clinical research study to evaluate the safety and efficacy of a drug/intervention. This is especially useful if the outcome measured is subjective. In clinical drug trials, a placebo is typically a drug that resembles the drug to be tested in certain characteristics such as color, size, shape and taste, but without the active substance. This helps to measure effects of just taking the drug, such as pain relief, compared to the drug with the active substance. If the effect is positive, for example, improvement in mood/pain, then it is called placebo effect. If the effect is negative, for example, worsening of mood/pain, then it is called nocebo effect. 21

The ethics of placebo‐controlled studies is complex and remains a debate in the medical research community. According to the Declaration of Helsinki on the use of placebo released in October 2013, “The benefits, risks, burdens and effectiveness of a new intervention must be tested against those of the best proven intervention(s), except in the following circumstances:

Where no proven intervention exists, the use of placebo, or no intervention, is acceptable; or

Where for compelling and scientifically sound methodological reasons the use of any intervention less effective than the best proven one, the use of placebo, or no intervention is necessary to determine the efficacy or safety of an intervention and the patients who receive any intervention less effective than the best proven one, placebo, or no intervention will not be subject to additional risks of serious or irreversible harm as a result of not receiving the best proven intervention.

Extreme care must be taken to avoid abuse of this option”. 22

Hence, while designing a research study, both the scientific validity and ethical aspects of the study will need to be thoroughly evaluated.

Bias has been defined as “any systematic error in the design, conduct or analysis of a study that results in a mistaken estimate of an exposure's effect on the risk of disease”. 23 There are multiple types of biases and so, in this review we will focus on the following types: selection bias, information bias and observer bias. Selection bias is when a systematic error is committed while selecting subjects for the study. Selection bias will affect the external validity of the study if the study subjects are not representative of the population being studied and therefore, the results of the study will not be generalizable. Selection bias will affect the internal validity of the study if the selection of study subjects in each group is influenced by certain factors, such as, based on the treatment of the group assigned. One of the ways to decrease selection bias is to select the study population that would representative of the population being studied, or to randomize (discussed in section “Randomization”).

Information bias is when a systematic error is committed while obtaining data from the study subjects. This can be in the form of recall bias when subject is required to remember certain events from the past. Typically, subjects with the disease tend to remember certain events compared to subjects without the disease. Observer bias is a systematic error when the study investigator is influenced by the certain characteristics of the group, that is, an investigator may pay closer attention to the group receiving the treatment versus the group not receiving the treatment. This may influence the results of the study. One of the ways to decrease observer bias is to use blinding (discussed in section “Blinding”).

Thus, while designing a study it is important to take measure to limit bias as much as possible so that the scientific validity of the study results is preserved to its maximum.

Overview of drug development in the United States of America

Now that we have reviewed the various clinical designs, clinical trials form a major part in development of a drug. In the United States, the Food and Drug Administration (FDA) plays an important role in getting a drug approved for clinical use. It includes a robust process that involves four different phases before a drug can be made available to the public. Phase I is conducted to determine a safe dose. The study subjects consist of normal volunteers and/or subjects with disease of interest, and the sample size is typically small and not more than 30 subjects. The primary endpoint consists of toxicity and adverse events. Phase II is conducted to evaluate of safety of dose selected in Phase I, to collect preliminary information on efficacy and to determine factors to plan a randomized controlled trial. The study subjects consist of subjects with disease of interest and the sample size is also small but more that Phase I (40–100 subjects). The primary endpoint is the measure of response. Phase III is conducted as a definitive trial to prove efficacy and establish safety of a drug. Phase III studies are randomized controlled trials and depending on the drug being studied, it can be placebo‐controlled, equivalence, superiority or non‐inferiority trials. The study subjects consist of subjects with disease of interest, and the sample size is typically large but no larger than 300 to 3000. Phase IV is performed after a drug is approved by the FDA and it is also called the post‐marketing clinical trial. This phase is conducted to evaluate new indications, to determine safety and efficacy in long‐term follow‐up and new dosing regimens. This phase helps to detect rare adverse events that would not be picked up during phase III studies and decrease in the delay in the release of the drug in the market. Hence, this phase depends heavily on voluntary reporting of side effects and/or adverse events by physicians, non‐physicians or drug companies. 2

We have discussed various clinical research study designs in this comprehensive review. Though there are various designs available, one must consider various ethical aspects of the study. Hence, each study will require thorough review of the protocol by the institutional review board before approval and implementation.

CONFLICT OF INTEREST

Chidambaram AG, Josephson M. Clinical research study designs: The essentials . Pediatr Invest . 2019; 3 :245‐252. 10.1002/ped4.12166 [ PMC free article ] [ PubMed ] [ CrossRef ] [ Google Scholar ]

An official website of the United States government

Here's how you know

The .gov means it’s official. Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

The site is secure. The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Clinical Research: Benefits, Risks, and Safety

On this page:

What are the potential benefits of participating in clinical research?

What are the potential risks of participating in clinical research, will i always get the experimental treatment in a clinical trial, how is the safety of clinical research participants protected.

If you’re interested in volunteering for clinical research, you may wonder: What makes a study a good fit for me? How do I know it’s safe? Clinical research involves studying health and illness in people through observational studies or clinical trials . Participating in a trial or study has many potential benefits and also some possible risks. Learn about the benefits and risks of participating in clinical research and how your safety is protected.

There are many possible benefits of being part of clinical research, including:

• You may have the chance to help scientists better understand your disease or condition and to advance treatments and ways to prevent it in the future.
• You may feel like you’re playing a more active role in your health.
• You may learn more about your disease or condition.
• You may be able to get information about support groups and resources.

In addition, some people participate in clinical trials because they hope to gain access to a potential new treatment for a disease before it is widely available.

Clinical trials and studies do come with some possible risks, including:

• The research may involve tests that pose a risk to participants. For example, certain physical tests may increase the chance of falling, and X-rays may cause a small increase in the risk of developing cancer.
• Participating in a study could also be inconvenient for you. For example, you may be required to have additional or longer medical appointments, more procedures, complex medication instructions, or hospital stays.

Additional risks of participating in clinical trials may include:

• For those who receive the experimental treatment, it may be uncomfortable or cause side effects (which can range from mild to serious).
• The experimental treatment might not work, or it may not be better than the standard treatment.
• For trials testing a new treatment, such as a new medication or device, you may end up not being part of the group that gets the experimental treatment. Instead, you may be assigned to the control (or comparison) group. In some studies, the control group receives a placebo, which is given in the same way as the treatment but has no effect.

Participant confidentiality is a concern in any kind of research. People other than the researchers, such as the study sponsors or experts who monitor safety, may be able to access medical information related to the study. Safeguards are in place to ensure that researchers tell potential participants what information could be shared and how their privacy will be protected before they consent to participate in research.

The study coordinators will provide detailed information and answer questions about the risks and benefits of participating in a particular study. Having this information can help you make an informed decision about whether to participate.

Clinical trial volunteers do not always get the treatment being tested. The gold standard for testing interventions in people is called a randomized controlled trial. Randomized means that volunteers are randomly assigned — chosen by chance — to receive either the experimental intervention (the test group) or a placebo or the current standard care (the control or comparison group). Then, researchers compare the effects in each group to determine whether the new treatment works.

When you enroll in a clinical trial, you may be assigned to the test group or to the control group. While participants in the control group do not receive the experimental treatment, these volunteers are just as important as those in the test group. Without the control group, scientists cannot be sure whether an experimental treatment is better than the standard or no treatment.

In many cases, you won’t know until the end of the trial whether you are in the test group or the control group. That’s because knowing the group assignment might influence the results of the trial. Studies are often “blinded” (or “masked”) to prevent this accidental bias. In a single-blind study, you are not told whether you are in the test group or the control group, but the research team knows. In a double-blind study, neither you nor the research team knows what group you are in until the trial is over. If medically necessary, however, it is always possible to find out which group you are in.

What is a placebo?

Whenever possible, clinical trials compare a new treatment for a specific condition to the standard treatment for that condition. When there is no standard treatment available, scientists may compare the new treatment to a placebo, which looks like the drug or treatment being tested but isn’t meant to actually change anything in your body. A pill that doesn’t contain any medicine is one example.

A trial that uses a placebo is described as a “placebo-controlled trial.” In this type of study, the test group receives the experimental treatment, and the control group receives the placebo.

Placebos are not used if an effective treatment is already available or if you would be put at risk by not having effective therapy. You will be told if placebos are used in the study before entering a trial as part of the process of informed consent.

What happens if a clinical trial ends early?

Most clinical trials run as planned from beginning to end. However, sometimes researchers end trials early. Clinical trials may be paused or stopped for a number of reasons:

• There is clear evidence that one intervention is more effective than another. When this happens, the trial may be stopped so that the new treatment can be made available to other people as soon as possible.
• The trial shows that the treatment doesn’t work or causes unexpected and serious side effects.
• The researchers can’t enroll enough people in the trial to provide meaningful results.

Even when a clinical trial ends early, it can still provide researchers with valuable information. For example, scientists may gain insights about how to best design and conduct clinical trials in a specific research area. In some cases, health information collected during a trial can lead to new potential therapies that researchers can test in the future.

Based on many years of experience and learning from past mistakes, strict rules are in place to keep participants safe . Today, every clinical investigator in the United States is required to monitor and make sure that every participant is safe. These safeguards are an essential part of the research.

Each clinical study follows a careful study plan, called a protocol, which describes what the researchers will do. The principal investigator, or head researcher, is responsible for ensuring the protocol is followed.

Safeguards to protect clinical research volunteers include Institutional Review Boards, informed consent, Data and Safety Monitoring Boards, and Observational Study Monitoring Boards.

• Most clinical studies in the U.S. must be approved by an Institutional Review Board (IRB) . The IRB is made up of doctors, scientists, and members of the general public who ensure that the study participants are not exposed to unnecessary risks. The people on the IRB regularly review the study and its results. They make sure that risks (or potential harm) to participants do not outweigh the potential benefits of the study.
• Informed consent also helps protect participants. Informed consent is the process by which you learn the key facts about a study before deciding whether to participate. Members of the research team explain the research before you start and throughout the study. They provide an informed consent document, which includes details about the study, such as its purpose, how long it will last, required procedures, and who to contact. The informed consent document also explains risks and potential benefits. You are free to ask questions, request more information, or withdraw from the study at any time.

Clinical trials and studies also have committees that monitor the safety of the research as it occurs.

• Clinical trials that test an intervention are closely supervised by a Data and Safety Monitoring Board . The board is made up of experts who review the results of the study as it progresses. If they determine that the experimental treatment is not working or is harming participants, they can stop the trial early.
• Observational Study Monitoring Boards monitor the safety of observational studies with large or vulnerable populations, or risks associated with tests or standard of care.

Several historical incidents have caused mistrust in clinical research. These events also led to the creation of laws that provide clinical research participants with multiple levels of protection.

One example is the U.S. Public Health Service Syphilis Study at Tuskegee , which was conducted between 1932 and 1972. In this study, researchers wanted to determine the effects of untreated syphilis. They did not explain the study’s risks or obtain informed consent from the participants, all of whom were Black men. They also did not offer the study participants penicillin when it became widely available in the mid-1940s, causing preventable illness and suffering. After news of the study leaked in 1972, it led to sweeping changes in standard research practices and guidelines to protect human research participants. Today, IRBs are responsible for reviewing all studies involving humans to ensure they meet these guidelines and for reporting any study plan that breaks the rules.

After obtaining all the information, you can make an informed decision about whether or not to participate in a clinical trial or study. If you decide to volunteer for clinical research, you will be given an informed consent form to sign. By signing the form, you show that you understand the details and want to be part of the research. However, the informed consent form is not a contract. You may leave the study at any time and for any reason.

Where can I find a clinical trial or study?

Looking for clinical research related to aging and age-related health conditions? There are many ways to find a trial or study. Talk to your health care provider and use online resources to:

• Search for a clinical trial or study .
• Look for clinical trials on Alzheimer’s disease, other dementias, and caregiving .
• Find a registry for a particular diagnosis or condition .
• Explore clinical trials and studies funded by NIA .

To learn more about a particular trial or study, you or your doctor can contact the research staff and ask questions. You can usually find contact information in the study description.

You may also be interested in

• Getting more information about clinical trials and studies
• Downloading and sharing an infographic with the benefits of participating in clinical research
• Learning about participating in Alzheimer's disease research

For more information about clinical research

Clinical Research Trials and You National Institutes of Health www.nih.gov/health-information/nih-clinical-research-trials-you

ClinicalTrials.gov www.clinicaltrials.gov 

U.S. Food and Drug Administration 888-463-6332 [email protected] www.fda.gov

This content is provided by the NIH National Institute on Aging (NIA). NIA scientists and other experts review this content to ensure it is accurate and up to date.

Content reviewed: May 18, 2023

nia.nih.gov

An official website of the National Institutes of Health

Transforming the understanding and treatment of mental illnesses.

Información en español

Celebrating 75 Years! Learn More >>

• Science News
• Meetings and Events
• Social Media
• Press Resources
• Email Updates
• Innovation Speaker Series

What is Clinical Research?

February 10, 2021

Clinical trials are part of clinical research and at the heart of all medical advances. Clinical trials look at new ways to prevent, detect, or treat disease. You might also hear clinical research referred to as clinical studies, clinical trials, studies, research, trials, or protocols.

People can participate either as a patient with a diagnosis or as a healthy volunteer.

People with the condition being studied may participate in studies that look at developing new treatments, identifying causes of illnesses, studying trends, or evaluating how genetics may be related to an illness.

Healthy volunteers are needed to compare their results to the results of people with the illness being studied.

Some studies do not require participants to change their current treatment, while other studies do. Studies might use brain scans, psychological tests, behavioral observation, or blood tests for genetic evaluation.

People participate in clinical trials for a variety of reasons. Healthy volunteers say they participate to help others and to contribute to moving science forward. Participants with an illness or disease also participate to help others, but also to possibly receive the newest treatment and to have the additional care and attention from the clinical trial staff.

Research is our best hope for understanding and treating mental illnesses. Thanks to help from volunteers, researchers are learning more and more about the causes of mental and behavioral disorders and are finding new ways to treat and prevent illnesses. Without this important relationship between research participants and those studying their illnesses, it would be much more difficult to improve health treatments.

Volunteers of all ethnic and cultural backgrounds are needed. By having a variety of volunteers participate, researchers can learn how different people react to medications and other treatments.

Thank you for your interest in learning more about clinical research!

Study record managers: refer to the Data Element Definitions if submitting registration or results information.

Search for terms

• About Amazon
• Investor Relations
• Amazon Devices
• Amazon Science
• Sell products on Amazon
• Sell on Amazon Business
• Sell apps on Amazon
• Become an Affiliate
• Advertise Your Products
• Self-Publish with Us
• Host an Amazon Hub
• › See More Make Money with Us
• Amazon Business Card
• Shop with Points
• Reload Your Balance
• Amazon Currency Converter
• Amazon and COVID-19
• Your Account
• Your Orders
• Shipping Rates & Policies
• Returns & Replacements
• Manage Your Content and Devices

• Conditions of Use
• Privacy Notice
• Consumer Health Data Privacy Disclosure
• Your Ads Privacy Choices

• Search Menu
• Sign in through your institution
• CNS Injury and Stroke
• Epilepsy and Sleep
• Movement Disorders
• Multiple Sclerosis/Neuroinflammation
• Neuro-oncology
• Neurodegeneration - Cellular & Molecular
• Neuromuscular Disease
• Neuropsychiatry
• Pain and Headache
• Advance articles
• Editor's Choice
• Author Guidelines
• Submission Site
• Why publish with this journal?
• Open Access
• About Brain
• Editorial Board
• Advertising and Corporate Services
• Journals Career Network
• Self-Archiving Policy
• Dispatch Dates
• Terms and Conditions
• Journals on Oxford Academic
• Books on Oxford Academic

Article Contents

Why we need a revolution in clinical research.

• Article contents
• Figures & tables
• Supplementary Data

Masud Husain, Why we need a revolution in clinical research, Brain , Volume 147, Issue 9, September 2024, Pages 2897–2898, https://doi.org/10.1093/brain/awae265

• Permissions Icon Permissions

We are at a pivotal moment for clinical research. In the UK, the system is fundamentally broken as recent reports have alluded to. 1 , 2 In other parts of the world too there are similar issues that are, at the very least, slowing down innovation and research. There are many factors that have been identified as contributing to this sad state of affairs in the UK. One important issue that has not attracted so much attention recently—though it was the subject of a report 3 in 2020—is the relationship between higher educational institutions (mostly universities) and healthcare providers (largely the National Health Service, NHS).

The vast majority of research activity in the UK occurs within the higher education sector, while most patient-related research such as clinical trials relies on NHS infrastructure. And this is where there is a massive disconnect. Each of these systems are huge, cumbersome behemoths, with their own local lumbering administrations focused on aims that are not aligned to the mission of producing rapid results in clinical research. In the university sector, the priorities of leaders are to keep the system financially afloat and minimize potential legal risks. Many institutions in the UK are on the cusp of fiscal ruin and so require grant and other research income to subsidize their existence. In the NHS on the other hand the aim is to cut waiting lists which, post pandemic and doctors’ industrial action, are now very lengthy, and to provide adequate service delivery. Making healthcare research effective and efficient is the last thing on the minds of the leadership of either sector.

But who can blame them? Surely, it’s difficult enough to run either a university or an NHS hospital? Indeed, this seems sufficient explanation—an adequate excuse—for some leaders of both these types of institution for the huge delays in getting any useful research done. Many teams are now waiting over a year to get their grant-funded research off the ground. Remarkably, some trials are failing because they never start, several years after the funding has been awarded. Material or data transfer agreements between universities; slothful legal reviews of contracts and agreements with third parties; calculating overheads to be charged; multiple reviews of research protocols by R&D departments; dragging of feet over costings independently for the university and hospital; sluggish reviews by research services; signing off contracts with the NHS; obtaining honorary contracts for non-clinical personnel; and many other procedures may take months, if not years, to complete. The system is both Byzantine and exasperating to navigate. No wonder that pharmaceutical companies are balking at initiating trials in the UK, their gaze turning instead to countries where they are more serious about getting things done sooner, not later. 1

So how do we get out of this mess? Given the narrow goals that the leaderships of universities and NHS hospitals have, we cannot expect a great deal more from them on this front— unless they are compelled to make changes. In the UK, when the National Institute for Health and Care Research (NIHR) was formed in 2006, many of us were under the impression that its mission really was to ‘create a health research system in which the NHS supports outstanding individuals, working in world-class facilities, conducting leading-edge research focused on the needs of patients and the public’. 4 Clearly though this just hasn’t happened. Otherwise, why the need for recent reports? 1 , 2

One of the key reasons for this failure (we cannot refer it to it as anything else) is the simple fact that universities and NHS infrastructure are not joined up. Many pretend to be, but it is obvious to anyone who works at even the best centres in the UK that this is a sham. At Oxford, one of the hospital networks calls itself the Oxford University Health NHS Foundation Trust, but there really is very little to suggest why ‘University’ should be in its title. The levels of duplication of work and contracting between the university and the hospital make a mockery of the concept of seamless integration between these institutions. It is the same elsewhere too. The result is a growing duopoly of administrations that negotiate with each other, waste time and slow the pace of progress. Even when a research proposal has been approved by a ‘joint’ R&D unit, there needs to be a costings agreement between university and NHS trust.

From a national perspective this makes little sense, either economically or for governance. We are in the bizarre situation where two sets of institution—universities and hospitals—both largely funded by taxpayers are independently setting their (growing) administrative staffs to scrutinize research protocols or haggle over costings on projects that are mostly funded by government or charities. It is even worse for multicentre studies when many different universities and NHS trusts each want a share of the pie. This has a hidden cost in numbers of people employed, researchers’ time dealing with paperwork, and an opportunity cost in terms of time taken to get studies off the ground. Furthermore, there is no incentive to do things better or faster. There is simply a parochial incentive to make money locally and mitigate risks locally . Until the day that universities and hospitals associated with them are compelled to work as one integrated unit, there is very little hope for change. We will be left in the current quagmire of structural indolence. And that is why we need a revolution. Writing more reports on the matter will not help.

It is interesting to reflect on the fact that it was also radical change that was necessary to bring medicine into the modern era—to make it based on observation, clinical examination and the scientific method—in the first place. From the confusing and sometimes bizarre practices that characterized medicine in the 18th century, there emerged a new way of doing things which came about within one generation and in perhaps one of the least advanced places in Europe for clinical science at that time: Paris. From being a backwater, the ‘Paris School of Medicine’ instigated such dramatic change that within 50 years it became the leading international centre for clinical practice, attracting physicians from around the world to learn about the ‘new medicine’. 5

The rise of scientific medicine in Paris depended on systematic correlation of physical examination findings on hundreds of patients with pathological findings at post-mortem; flexibility to revise diagnoses on the basis of these assessments; deployment of statistics, including data on mortality; and most of all on conducting this work and teaching it to medical students in hospitals. 5 What made this possible was reform. Before the French Revolution, control of medical care rested largely with the Church. With the reform of medical education that came after the Revolution, hospitals were centralized and their administration was overseen by the state. Fundamental changes in the way in which faculties of medicine were organized in France led the way for dramatic new ways of learning from patients and disseminating knowledge to clinicians. Medical education was transformed but it needed the convulsive change of a Revolution to make this happen. 6 It required top-down edicts to bring about change because there was no incentive for the old institutions to make those changes themselves.

We are now confronted with a similar problem. The old institutions—universities and hospitals—are used to doing things their way. There is no incentive for them to change unless the state or its organs of power intervene. In the UK, NIHR funds now support Biomedical Research Centres (BRCs) which supposedly cross universities and NHS hospital trusts, but in truth the fiscal support helps to prop up university research personnel with very little going to the NHS. Most importantly, the NIHR has not insisted on BRCs having joined up (i.e. single) integrated, university-NHS systems in place, or for seamless national transfer of approvals across sites without the need for new sets of contractual agreements. Nothing fundamental will change unless it or the new government compels this change. The pursuit of national interests requires national leadership to intervene; we can't rely on local, devolved institutions to make the obvious decisions that are required. This is why we need a revolution in healthcare research.

O’Shaughnessy J . Commercial clinical trials in the UK: The Lord O’Shaughnessy review - final report. Accessed 13 August 2024. https://www.gov.uk/government/publications/commercial-clinical-trials-in-the-uk-the-lord-oshaughnessy-review/commercial-clinical-trials-in-the-uk-the-lord-oshaughnessy-review-final-report

The Academy of Medical Sciences . Future-proofing UK health research: A people-centred, coordinated approach. https://acmedsci.ac.uk/file-download/23875189

The Academy of Medical Sciences . Transforming health through innovation: integrating the NHS and academia. https://acmedsci.ac.uk/file-download/23932583

Department of Health and Social Care . Best research for best health: a new national health research strategy. https://www.gov.uk/government/publications/best-research-for-best-health-a-new-national-health-research-strategy

La Berge A , Hannaway C . Paris medicine: Perspectives past and present . Clio Med . 1998 ; 50 : 1 – 69 .

Google Scholar

Ackerknecht EH . Medicine at the Paris hospital, 1794–1848 . Johns Hopkins University Press ; 1967 .

Google Preview

Email alerts

Citing articles via, looking for your next opportunity.

• Contact the editorial office
• Guarantors of Brain
• Recommend to your Library

Affiliations

• Online ISSN 1460-2156
• Print ISSN 0006-8950
• Copyright © 2024 Guarantors of Brain
• About Oxford Academic
• Publish journals with us
• University press partners
• What we publish
• New features  
• Open access
• Institutional account management
• Rights and permissions
• Get help with access
• Accessibility
• Advertising
• Media enquiries
• Oxford University Press
• Oxford Languages
• University of Oxford

Oxford University Press is a department of the University of Oxford. It furthers the University's objective of excellence in research, scholarship, and education by publishing worldwide

• Copyright © 2024 Oxford University Press
• Cookie settings
• Cookie policy
• Privacy policy
• Legal notice

This Feature Is Available To Subscribers Only

Sign In or Create an Account

This PDF is available to Subscribers Only

For full access to this pdf, sign in to an existing account, or purchase an annual subscription.

• Skip to main content
• Skip to FDA Search
• Skip to in this section menu
• Skip to footer links

The .gov means it’s official. Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you're on a federal government site.

The site is secure. The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

U.S. Food and Drug Administration

•   Search
•   Menu
• For Patients
• Learn About Drug and Device Approvals
• The Drug Development Process

Step 3: Clinical Research

While preclinical research answers basic questions about a drug’s safety, it is not a substitute for studies of ways the drug will interact with the human body. “Clinical research” refers to studies, or trials, that are done in people. As the developers design the clinical study, they will consider what they want to accomplish for each of the different Clinical Research Phases and begin the Investigational New Drug Process (IND), a process they must go through before clinical research begins.

On this page you will find information on:

Designing Clinical Trials

Clinical Research Phase Studies

The Investigational New Drug Process

Asking for FDA Assistance

FDA IND Review Team

Researchers design clinical trials to answer specific research questions related to a medical product. These trials follow a specific study plan, called a protocol , that is developed by the researcher or manufacturer. Before a clinical trial begins, researchers review prior information about the drug to develop research questions and objectives. Then, they decide:

Who qualifies to participate (selection criteria)

How many people will be part of the study

How long the study will last

Whether there will be a control group and other ways to limit research bias

How the drug will be given to patients and at what dosage

What assessments will be conducted, when, and what data will be collected

How the data will be reviewed and analyzed

Clinical trials follow a typical series from early, small-scale, Phase 1 studies to late-stage, large scale, Phase 3 studies.

What are the Clinical Trial Phases?

Watch this video to learn about the three phases of clinical trials.

Study Participants: 20 to 100 healthy volunteers or people with the disease/condition.

Length of Study: Several months

Purpose: Safety and dosage

During Phase 1 studies, researchers test a new drug in normal volunteers (healthy people). In most cases, 20 to 80 healthy volunteers or people with the disease/condition participate in Phase 1. However, if a new drug is intended for use in cancer patients, researchers conduct Phase 1 studies in patients with that type of cancer.

Phase 1 studies are closely monitored and gather information about how a drug interacts with the human body. Researchers adjust dosing schemes based on animal data to find out how much of a drug the body can tolerate and what its acute side effects are.

As a Phase 1 trial continues, researchers answer research questions related to how it works in the body, the side effects associated with increased dosage, and early information about how effective it is to determine how best to administer the drug to limit risks and maximize possible benefits. This is important to the design of Phase 2 studies.

Approximately 70% of drugs move to the next phase

Study Participants: Up to several hundred people with the disease/condition.

Length of Study: Several months to 2 years

Purpose: Efficacy and side effects

In Phase 2 studies, researchers administer the drug to a group of patients with the disease or condition for which the drug is being developed. Typically involving a few hundred patients, these studies aren't large enough to show whether the drug will be beneficial.

Instead, Phase 2 studies provide researchers with additional safety data. Researchers use these data to refine research questions, develop research methods, and design new Phase 3 research protocols.

Approximately 33% of drugs move to the next phase

Study Participants: 300 to 3,000 volunteers who have the disease or condition

Length of Study: 1 to 4 years

Purpose: Efficacy and monitoring of adverse reactions

Researchers design Phase 3 studies to demonstrate whether or not a product offers a treatment benefit to a specific population. Sometimes known as pivotal studies, these studies involve 300 to 3,000 participants.

Phase 3 studies provide most of the safety data. In previous studies, it is possible that less common side effects might have gone undetected. Because these studies are larger and longer in duration, the results are more likely to show long-term or rare side effects

Approximately 25-30% of drugs move to the next phase

Study Participants: Several thousand volunteers who have the disease/condition

Purpose: Safety and efficacy

Phase 4 trials are carried out once the drug or device has been approved by FDA during the Post-Market Safety Monitoring

Learn more about Clinical Trials .

Drug developers, or sponsors , must submit an Investigational New Drug (IND) application to FDA before beginning clinical research.

In the IND application, developers must include:

Animal study data and toxicity (side effects that cause great harm) data

Manufacturing information

Clinical protocols (study plans) for studies to be conducted

Data from any prior human research

Information about the investigator

Drug developers are free to ask for help from FDA at any point in the drug development process, including:

Pre-IND application, to review FDA guidance documents and get answers to questions that may help enhance their research

After Phase 2, to obtain guidance on the design of large Phase 3 studies

Any time during the process, to obtain an assessment of the IND application

Even though FDA offers extensive technical assistance, drug developers are not required to take FDA’s suggestions. As long as clinical trials are thoughtfully designed, reflect what developers know about a product, safeguard participants, and otherwise meet Federal standards, FDA allows wide latitude in clinical trial design.

The review team consists of a group of specialists in different scientific fields. Each member has different responsibilities.

Project Manager: Coordinates the team’s activities throughout the review process, and is the primary contact for the sponsor.

Medical Officer: Reviews all clinical study information and data before, during, and after the trial is complete.

Statistician: Interprets clinical trial designs and data, and works closely with the medical officer to evaluate protocols and safety and efficacy data.

Pharmacologist: Reviews preclinical studies.

Pharmakineticist: Focuses on the drug’s absorption, distribution, metabolism, and excretion processes.Interprets blood-level data at different time intervals from clinical trials, as a way to assess drug dosages and administration schedules.

Chemist: Evaluates a drug’s chemical compounds. Analyzes how a drug was made and its stability, quality control, continuity, the presence of impurities, etc.

Microbiologist: Reviews the data submitted, if the product is an antimicrobial product, to assess response across different classes of microbes.

The FDA review team has 30 days to review the original IND submission. The process protects volunteers who participate in clinical trials from unreasonable and significant risk in clinical trials. FDA responds to IND applications in one of two ways:

Approval to begin clinical trials.

Clinical hold to delay or stop the investigation. FDA can place a clinical hold for specific reasons, including:

Participants are exposed to unreasonable or significant risk.

Investigators are not qualified.

Materials for the volunteer participants are misleading.

The IND application does not include enough information about the trial’s risks.

A clinical hold is rare; instead, FDA often provides comments intended to improve the quality of a clinical trial. In most cases, if FDA is satisfied that the trial meets Federal standards, the applicant is allowed to proceed with the proposed study.

The developer is responsible for informing the review team about new protocols, as well as serious side effects seen during the trial. This information ensures that the team can monitor the trials carefully for signs of any problems. After the trial ends, researchers must submit study reports.

This process continues until the developer decides to end clinical trials or files a marketing application. Before filing a marketing application, a developer must have adequate data from two large, controlled clinical trials.

Study at Cambridge

About the university, research at cambridge.

• Undergraduate courses
• Events and open days
• Fees and finance
• Postgraduate courses
• How to apply
• Postgraduate events
• Fees and funding
• International students
• Continuing education
• Executive and professional education
• Courses in education
• How the University and Colleges work
• Term dates and calendars
• Visiting the University
• Annual reports
• Equality and diversity
• A global university
• Public engagement
• Give to Cambridge
• For Cambridge students
• For our researchers
• Business and enterprise
• Colleges & departments
• Email & phone search
• Museums & collections
• Course Directory

MPhil in Foundations of Clinical Psychology

Postgraduate Study

• Why Cambridge overview
• Chat with our students
• Cambridge explained overview
• The supervision system
• Student life overview
• In and around Cambridge
• Leisure activities
• Student union
• Music awards
• Student support overview
• Mental health and wellbeing
• Disabled students
• Language tuition
• Skills training
• Support for refugees
• Courses overview
• Department directory
• Qualification types
• Funded studentships
• Part-time study
• Research degrees
• Visiting students
• Finance overview
• Fees overview
• What is my fee status?
• Part-time fees
• Application fee
• Living costs
• Funding overview
• Applying for University funding
• Doctoral training programmes
• External funding and loans
• Colleges overview
• College listing overview
• Accommodation
• Applying overview
• Before you apply
• Entry requirements
• Application deadlines
• How do I apply? overview
• Application fee overview
• Application fee waiver
• Life Science courses
• Terms and conditions
• Continuing students
• Disabled applicants
• Supporting documents overview
• Academic documents
• Finance documents
• Evidence of competence in English
• AI and postgraduate applications
• Terms and Conditions
• Applicant portal and self-service
• After you apply overview
• Confirmation of admission
• Student registry
• Previous criminal convictions
• Deferring an application
• Updating your personal details
• Appeals and Complaints
• Widening participation
• Postgraduate admissions fraud
• International overview
• Immigration overview
• ATAS overview
• Applying for an ATAS certificate
• Current Cambridge students
• International qualifications
• Competence in English overview
• What tests are accepted?
• International events
• International student views overview
• Akhila’s story
• Alex’s story
• Huijie’s story
• Kelsey’s story
• Nilesh’s story
• Get in touch!
• Events overview
• Upcoming events
• Postgraduate Open Days overview
• Discover Cambridge: Master’s and PhD Study webinars
• Virtual tour
• Research Internships
• How we use participant data
• Postgraduate Newsletter

Primary tabs

• Study (active tab)
• Requirements
• How To Apply

The taught component of this course is approximately 140 hours.  Taught component assessments count for 40% of the final mark.  Modules offered include:

• Data Analysis and Scientific Computing:  This module consists of 4 sessions and covers Introduction to a scientific programming tool (either R or Python); Basic data analysis and manipulation; Introduction to programming and automation; Introduction to data visualisation commands
• Core Statistics:  1 and 2 sample tests, both parametric and non-parametric;; 1-way ANOVA, Kruskal Wallace and relevant post-hoc testing; Simple linear regression; 2-way ANOVA; ANCOVA and regression on grouped data; Linear models and interactions; Power analyses.
• Reproducible research skills:  Issues surrounding reproducibility;  Data organisation and management; Literate programming and version control
• Visual Data Presentation: Background to good data visualisation practices; Advanced plotting techniques; Presentation and discussion of effective visualisation
• Robust Behavioral Sciences (16 hrs):  This module will encourage students to think critically about how behavioural research is conducted and how conclusions are drawn; how scientists are incentivised, how they publish and how their beliefs influence the inferences they make; multiple methodological, statistical, and systematic issues that could impair the robustness of scientific claims and new initiatives that are reinventing the foundations of our field.
• Mental Health and Well-Being: Definitions, Diagnosis, and Differences (20 hrs):  This is an introduction to psychological theoretical frameworks with an integrative, multimodal, perspective as appropriate and adapted to circumstance and context. 
• Psychological Therapy and Clinical Psychology:  Theoretical Frameworks (20 hrs):  Students will develop an understanding of formulation and the implementation of psychologically informed interventions, as appropriate to the presenting problem and to the psychological and social circumstances of the client. Therapeutic techniques will be introduced, and processes as applied when working with a range of different individuals in distress.
• Governance of Clinical Practice (20 hrs): Introduction to the legislative and national planning contexts for service delivery and clinical practice in the UK with some attention to these issues in other countries. Leadership qualities will be considered.
• Public Mental Health (20 hrs): Covers key clinical and epidemiological concepts that influence mental health epidemiology and public health according to place, time and person; the principles of social determinants of health along the life-course in mental health; how genetics influences mental health and the complexity of gene-environment interactions in psychiatry; life stressors and how they affect negative and positive mental health outcomes;  intersectionality of mental health disorders and the problems that most mental health classifications systems present.
• Evaluating Practice:  Process, Outcomes, and Experience (20 hrs):  Covers evidence-based therapy outcome measures in relation to recovery, values and goals and as informed by service user experiences as well as clinical indicators.  The importance of self-awareness and working as a reflective practitioner within ethical and professional practice frameworks will be discussed.

One to one supervision

Students will have approximately 44 hours of supervision and tutorials throughout the academic year as follows: Small group or individual supervision Approx. forty hours of the taught component of the course will be provided in small seminar groups across the academic year. There are approximately 100 hours per academic year of lectures. Student-directed elements (in which students will contribute towards the selection of topic) will include journal club presentations and discussions, each focused around a research paper, controversial topic or state-of-the-art technique. These will be supported by more experienced researchers from the host department, including experience PhD students, who will act as facilitators to provide guidance, structure and assurance of integrity, accuracy and quality of discussions.   A minimum of 10 hours of journal clubs will be available across the academic year. As part of their Extended Research Project, students will be required to complete a  literature review of the field (max 5000 words), providing the background to, and context for, the research project.  The literature review comprises 50% of the research project final mark.  As an integral part of the research project, students will present  their findings with a poster presentation.   The presentation will be assessed for presentation of scientific findings including  layout of the poster, clarity of data presentation, and overall ability to deliver a clear and engaging oral presentation of the poster.  This assessment contributes to the Research Project outcomes mark which is 50% of the total Research project final mark. Students will have the opportunity to work in clinical services in Cambridgeshire County  including NHS and County Council statutory and third sector organisations.  Placements will include 2day/week over the course of the second or third term. Placement activities will include, undertaking a service-related audit using service data; co-leading group therapy with a registered professional; scoring neuropsychological assessments and helping to prepare assessment reports; compiling developmental histories; and other activities that will enable to student to experience mental health services first hand.  Students will receive ongoing feedback from supervisors and tutors. In addition, the principal supervisor will write termly online reports which can be accessed by the student. Students will receive face-to-face supervision throughout each term, with the duration and frequency depending on the nature of the project. The University of Cambridge publishes an annual  Code of Practice  which sets out the University’s expectations regarding supervision. Thesis / Dissertation The Research Project comprises 40% of the final mark.   The research project will begin in November and run for 32 weeks.  Students will be based one day/week during term time in the research group of the research programme in which their research project is embedded. Students are expected to spend approximately 75 hours each term working on their thesis. Students will be given a list of potential projects to choose from.  The course will have an assigned advisor to meet with students and guide them through the available projects. Students will be given time and support in the first 4 weeks of Michaelmas term to meet with course supervisors and lab based research leads to discuss potential projects, and to develop a research project outline.  They will be required to submit a brief project plan prior to beginning work on the project, for approval by the course leadership team. This will allow the Course Directors to give guidance to students and supervisors on the scale and scope of this project to ensure that it is deliverable within the timeframe and meets the high standards expected. Students will write up their research project as two components: A literature review of the field (max 5000 words), providing the background to, and context for, the research project (50% of final mark) The project outcomes : Aims, methods, results, data analysis and discussion (50% of the final mark) (max 5000 words) The taught component of the course compromises 40% of the final mark and will be assessed by the following written papers, essays and presentations:  five case studies on topics announced by the Degree Committee for the Faculties of Clinical Medicine and Veterinary Medicine (by submission of papers no more than 750 words); a Public Health essay of no more than 2,500 words;  an essay of no more than 2,500 words comparing three contrasting research papers, on a topic chosen from a specified list. The Clinical Placement compromises 20% of the final mark and will be assessed by a short essay (1500 words) on one of the following topics: a Case Assessment, eg neuropsychological assessment; group therapy OR a Service audit.  Written examination The following taught modules will be assessed, in part, by  multiple choice question exam: Mental Health and Well-Being: Definitions, Diagnosis, and Differences Psychological Therapy and Clinical Psychology:  Theoretical Frameworks Governance of Clinical Practice The Biostatistics course will be assessed  by a written examination. Practical assessment The module, Evaluating Practice:  Process, Outcomes, and Experienc e, will be assessed by two oral case presentations each 20 minutes long. The student will be given case details in advance.  Students will be asked to present the cases as though in clinical supervision.  Presentations will be scored in relation to elements of formulation and diagnosis; treatment planning; outcome measures ; and planning for treatment review with the service user. Key Information 10 months full-time, study mode : taught, master of philosophy, department of psychiatry, course - related enquiries, application - related enquiries, course on department website, dates and deadlines:, michaelmas 2025. Some courses can close early. See the Deadlines page for guidance on when to apply. Funding Deadlines These deadlines apply to applications for courses starting in Michaelmas 2025, Lent 2026 and Easter 2026. Similar Courses Psychiatry PhD Medical Science (Psychiatry) MPhil Clinical Medicine Wellcome Trust PhD Postgraduate Admissions Office Admissions statistics Start an application Applicant Self-Service At a glance Bringing a family Current Postgraduates Cambridge Students' Union (SU) University Policy and Guidelines Privacy Policy Information compliance Equality and Diversity Terms of Study About this site About our website Privacy policy © 2024 University of Cambridge Contact the University Accessibility Freedom of information Privacy policy and cookies Statement on Modern Slavery University A-Z Undergraduate Postgraduate Research news About research at Cambridge Spotlight on... Request Information Clinical Research Management Graduate Certificate Jump start your career in the rapidly expanding field of clinical research Ohio State’s online Clinical Research Management Graduate Certificate prepares healthcare professionals and students in any field to be leaders in the management of human subjects research. With this clinical research certificate, you’ll build a solid foundation in clinical research management and learn how to apply bioethical standards to the medical development and innovation of complex clinical research studies in the healthcare and biopharmaceutical environments. Coursework for the online Clinical Research Management graduate certificate meets the major competencies established by the Joint Task Force Core Competencies for Clinical Research Professionals . Ready for a bigger step? If you choose to continue your education in clinical research, you may transfer 100% of the certificate’s course credits into Ohio State’s online  Master of Clinical Research degree program . Completion of the certificate program does not guarantee admission to the graduate program. "There have been days at work when I think to myself, ‘I just learned about that last night’. It’s really exciting when you can actually see that come to be a part of your work day." "Being able to apply everything I was working on for school immediately to my work was my favorite part of the program." "I could not have faced so many obstacles without the support, strength and guidance from the faculty and staff. Even when times were tough, they believed in me, so I believed in me." Frequently asked questions, is the program 100% online are any campus visits required. This program can be completed 100% online with no campus visits required. How flexible are online classes? What is my expected time commitment? Online programs are Ohio State are designed for working professionals. The amount of credits you schedule will help determine how long it will take to complete your program. Your expected time commitment will vary based on your course load, but for every credit hour you are enrolled in, expect to complete three hours of work outside of class for studying or projects. What does an online classroom look like? Online courses at Ohio State are different from on-campus courses. We have designed online courses to take advantage of the benefits of the virtual experience, including connecting to outside people and ideas, presenting information, and engaging in discussions with your classmates and faculty. Related Content Top 4 Things to Ask When Considering an Online Program Learn the top 4 things to consider when weighing your options for pursuing an online degree from an Ohio State academic advisor. Are Online Degrees Respected? Learn how a degree from one of the best colleges online can help you stand out to employers and get a job. How Much Does Online College Cost? Calculate the cost of an online degree, and discover the best online degree for you and your budget. Academic Calendar Multiple start dates are offered during the academic calendar year for The Ohio State University College of Nursing’s online non-degree programs, so you can decide when to take the next step toward earning your Clinical Research Management Graduate Certificate. Spring 2025 Application Deadline November 1, 2024 Term Start Date January 6, 2025 Summer 2025 Application Deadline March 1, 2025 Term Start Date May 6, 2025 Autumn 2025 Application Deadline June 18, 2025 Term Start Date August 26, 2025 Admission Criteria To enroll in the online Clinical Research Management Graduate Certificate program, you must: Be a U.S. citizen or permanent resident Have a baccalaureate degree in a health related discipline Hold a minimum 3.0 cumulative GPA on a 4.0 scale in the last degree earned that is relevant to the program of study The State Authorization Reciprocity Agreement, also known as  SARA , establishes uniform standards for distance education for all participating states and institutions. Ohio State joined SARA in 2015, which means Ohio State can offer most online and on-ground courses and programs in  SARA member states, districts and territories without seeking authorization in each state. Career Outlook This online graduate-level Clinical Research Management certificate will prepare you for your next steps with a broad foundation of knowledge and skills in human subjects’ research regulations, conduct, management and leadership. Whether you’re looking to grow in your current career or make a career change altogether, Ohio State’s online programs can help you achieve your goals. Learn what the outlook is for your current or next career move using O*Net’s My Next Move tool. The Clinical Research Management certificate includes 12 credits of graduate coursework, is offered 100% online and asynchronously and is designed to be able to be completed in three semesters. The curriculum meets the internationally recognized Joint Task Force for Clinical Trial Competency framework. NURSING 7781 – Responsible Conduct of Research Concepts and policies for the responsible conduct of research (RCR), Institutional Review Boards (IRB) and dissemination of findings will be introduced.  MCR 7770 – Fundamentals of Medical Product Development and Regulation Function of clinical research in medical product development and the regulatory process of new medical products. Laws and regulations concerning the development, testing, commercialization, and total product life cycle for medical products. Regulations governing the conduct of clinical research, including study sponsors, investigators, and Institutional Review Boards. MCR 7405 – Clinical Research Study and Site Management Fundamental principles of clinical research operations from study site selection to study closure from the perspective of sponsors and clinical research sites including an introduction to database design, management, quality assurance, and reporting for site and sponsor operations. MCR 7482 – Principles of Quality Management for Medical Product Development This course covers concepts and application of total quality management for federal regulation of medical product development including drugs and medical devices. (Offered: Summer semester) MCR 7404 – Project Management for Healthcare and Clinical Research This course covers the principles of project management and strategic planning in healthcare, clinical research, and regulatory settings. (Offered: Summer semester) MCR 7481 – Data Management and Informatics in Clinical Research This course provides an introduction to fundamental principles of clinical research data management and informatics to include the acquisition and management of data during clinical research studies, including source data, data entry, data quality assurance, reporting, and security. (Offered: Spring semester) Understanding Online Course Types As you research the right online program for you, you likely will come across the terms “asynchronous” and “synchronous.” Learn what these terms mean and how they’re important to consider when understanding how a program will fit into your life. Program Faculty The online courses in Ohio State’s Clinical Research Management Graduate Certificate are led by esteemed College of Nursing faculty. The Ohio State University College of Nursing is recognized by the National League for Nursing as a Center of Excellence for Creating Environments that Enhance Student Learning and Professional Development. Jessica Fritter, DHSc, MACPR, ACRP-CP “There is a national demand for clinical research professionals. This certificate offers students a broad foundation in the management of human subjects research and credible educational credentials to break into the clinical research industry or advance their career.” Carolynn Jones, DNP, MSPH, RN, FAAN Amy Mackos, PhD Testimonials Find out how online learning has helped Ohio State students succeed. “I could not have faced so many obstacles without the support, strength and guidance from the faculty and staff. Even when times were tough, they believed in me, so I believed in me.” “Ohio State is a large institution with a lot of possibilities and opportunities. You will meet people who you can connect with and who will connect you with others.” “being able to apply everything i was working on for school immediately to my work was my favorite part of the program.”, get started. Speak with a knowledgeable Enrollment Advisor who can help answer your questions and explain different aspects of the more than 70 online degrees and certificates offered at Ohio State. 388 IMAGES What Is Clinical Research? What is Clinical Research? What Are Clinical Trials and Studies? clinical research What Are Clinical Trials and Studies? Clinical Studies VIDEO What makes a good clinical research study by Dr. Muayad Albadrani 1-3- Types of Clinical Research What to Expect When Participating in a Paid Clinical Trial at Altasciences LA Opiod-Induced Constipation Study Commercial Paid Clinical Research Study Cardiovascular Clinical Trial in Las Vegas COMMENTS Clinical Research What is It Many clinical research studies are also supervised by a data and safety monitoring committee. This is a group made up of experts in the area being studied. These biomedical professionals regularly monitor clinical studies as they progress. If they discover or suspect any problems with a study, they immediately stop the trial. Basics About Clinical Trials Clinical trials are conducted for many reasons: to determine whether a new drug or device is safe and effective for people to use. to study different ways to use standard treatments or current ... What Are Clinical Trials and Studies? Clinical research is the study of health and illness in people. There are two main types of clinical research: observational studies and clinical trials. Read and share this infographic (PDF, 317K) to learn why researchers do different kinds of clinical studies. Observational studies monitor people in normal settings. About Clinical Studies Observational study. A type of study in which people are observed or certain outcomes are measured. No attempt is made by the researcher to affect the outcome — for example, no treatment is given by the researcher. Clinical trial (interventional study). During clinical trials, researchers learn if a new test or treatment works and is safe. Clinical research The term "clinical research" refers to the entire process of studying and writing about a drug, a medical device or a form of treatment, which includes conducting interventional studies (clinical trials) or observational studies on human participants.[1] [3] Clinical research can cover any medical method or product from its inception in the lab to its introduction to the consumer market and ... Clinical Trials and Clinical Research: A Comprehensive Review Clinical research is an alternative terminology used to describe medical research. Clinical research involves people, and it is generally carried out to evaluate the efficacy of a therapeutic drug, a medical/surgical procedure, or a device as a part of treatment and patient management. ... The clinical study majorly includes the collection and ... What is Clinical Research? Office of Inspector General. USA.gov. NIH…Turning Discovery Into Health ®. National Institutes of Health, 9000 Rockville Pike, Bethesda, Maryland 20892. U.S. Department of Health and Human Services. Clinical research occurs in many formats and can involve anyone. Learn how you can participate and contribute to medical advances. What is a Clinical Trial? Clinical trials look at new ways to prevent, detect, or treat disease. The goal of clinical trials is to determine if a new test or treatment works and is safe. The idea for a clinical trial —also known as a clinical research study —often originates in the laboratory. After researchers test new therapies or procedures in the laboratory and ... The Basics Clinical research includes all research that involves people. Types of clinical research include: Epidemiology, which improves the understanding of a disease by studying patterns, causes, and effects of health and disease in specific groups. Behavioral, which improves the understanding of human behavior and how it relates to health and disease. Let's Talk About Clinical Research These include research study, experiment, medical research and clinical trial. A clinical trial is research to answer specific questions about new therapies or new ways of using known treatments. Clinical trials take place in phases. For a treatment to become standard, it usually goes through two or three clinical trial phases. Understanding Clinical Studies Understanding Clinical Studies. Part of the challenge of explaining clinical research to the public is describing the important points of a study without going into a detailed account of the study's design. There are many different kinds of clinical studies, each with their own strengths and weaknesses, and no real shorthand way to explain them. Clinical trials Clinical trials are a type of research that studies new tests and treatments and evaluates their effects on human health outcomes. People volunteer to take part in clinical trials to test medical interventions including drugs, cells and other biological products, surgical procedures, radiological procedures, devices, behavioural treatments and preventive care. What is Clinical Research? Before a clinical research study or clinical trial begins, an administrative group known as the Institutional Review Board reviews the plan and makes sure it's safe for participants. The Board consists of medical professionals, ethics experts, and people from the community. A study can't start recruiting until the board approves it. Planning and Conducting Clinical Research: The Whole Process After selecting a single conceptual framework or a combination of a few frameworks, a clinical study can be completed in two fundamental steps: study design and study report. Three study designs should be planned in sequence and iterated until satisfaction: the theoretical design, data collection design, and statistical analysis design [7]. What Are the Different Types of Clinical Research? Clinical trials are a kind of clinical research designed to evaluate and test new interventions such as psychotherapy or medications. Clinical trials are often conducted in four phases. What Are Clinical Trials? Most cancer clinical trials are treatment studies that involve people who have cancer. These trials test new treatments or new ways of using existing treatments, including new: drugs. vaccines. approaches to surgery or radiation therapy. combinations of treatments. As researchers learn more about the genetic changes that lead to cancer, doctors ... Clinical Research Trials and You: Questions and Answers A clinical trial is a research study that involves people like you. Researchers conduct clinical trials to find new or better ways to prevent, detect, or treat health conditions. Often, researchers want to find out if a new test, treatment, or preventive measure is safe and effective. Tests can include ways to screen for, diagnose, or prevent a ... Clinical research study designs: The essentials Introduction. In clinical research, our aim is to design a study, which would be able to derive a valid and meaningful scientific conclusion using appropriate statistical methods that can be translated to the "real world" setting. 1 Before choosing a study design, one must establish aims and objectives of the study, and choose an appropriate target population that is most representative of ... Clinical Research: Benefits, Risks, and Safety Clinical research involves studying health and illness in people through observational studies or clinical trials. Participating in a trial or study has many potential benefits and also some possible risks. Learn about the benefits and risks of participating in clinical research and how your safety is protected. What is Clinical Research? Clinical trials are part of clinical research and at the heart of all medical advances. Clinical trials look at new ways to prevent, detect, or treat disease. You might also hear clinical research referred to as clinical studies, clinical trials, studies, research, trials, or protocols. Clinical Research Versus Medical Treatment research. trials. protocols. Clinical research may have a number of goals, such as: developing new treatments or medications. identifying causes of illness. studying trends. evaluating ways in ... ClinicalTrials.gov Clinical study. A research study involving human volunteers (also called participants) that is intended to add to medical knowledge. There are two types of clinical studies: Clinical trial. ClinicalTrials.gov identifier (NCT number) The unique identification code given to each clinical study upon at ClinicalTrials.gov. Orthopedic Clinical Research Clinical Studies and Research Grants Practice-Changing Orthopedic Research . PREVENT CLOT: Supported by $12 million in funding from PCORI and led by Robert V. O'Toole, MD, the "PREVENT CLOT" trial is the largest orthopedic trauma trial ever, as it evaluated 12,211 patients with pelvic, acetabular, or extremity fractures treated operatively. It ... Special Research Topic: Right of Withdrawal The study team of the clinical trial you are participating in is there to support you in your decision and help you navigate the withdrawal process. Will withdrawing from a study affect the results? Because clinical trial data is necessary to understand whether a drug is safe and effective, the more individuals who fully complete the study, the ... Amazon.com: The Sourcebook for Clinical Research: A Practical Guide for Study Conduct. ... Clinical Trials: Study Design, Endpoints and Biomarkers, Drug Safety, and FDA and ICH Guidelines. 4.2 4.2 out of 5 stars 26 4.2 out of 5 stars. 26 customer reviews. Only 1 left in stock - order soon. Back to top Why we need a revolution in clinical research We are at a pivotal moment for clinical research. In the UK, the system is fundamentally broken as recent reports have alluded to. 1, 2 In other parts of the world too there are similar issues that are, at the very least, slowing down innovation and research. There are many factors that have been identified as contributing to this sad state of affairs in the UK. Step 3: Clinical Research Researchers design clinical trials to answer specific research questions related to a medical product. These trials follow a specific study plan, called a protocol , that is developed by the ... MPhil in Foundations of Clinical Psychology an essay of no more than 2,500 words comparing three contrasting research papers, on a topic chosen from a specified list. The Clinical Placement compromises 20% of the final mark and will be assessed by a short essay (1500 words) on one of the following topics: a Case Assessment, eg neuropsychological assessment; group therapy OR; a Service audit. How to Be a Clinical Psychologist: What You Should Learn Clinical psychology is a fast-growing field, and the number of psychologists has significantly risen in the 21st century. According to the U.S. Bureau of Labor Statistics, nearly 72,000 clinical and counseling psychologists are currently practicing in the United States.. According to the U.S. Bureau of Labor Statistics, that already large number is projected to increase by approximately 11% by ... Clinical Research Management Graduate Certificate Fundamental principles of clinical research operations from study site selection to study closure from the perspective of sponsors and clinical research sites including an introduction to database design, management, quality assurance, and reporting for site and sponsor operations. essay homework paper phd project resume review speech thesis