The table below describes the characteristics of new protocols containing RWD as well as protocol amendments that added RWD to a study that did not previously include RWD. The numbers include submissions of interventional study protocols to an IND and submissions of non-interventional study protocols to an existing IND or to a pre-IND. The numbers do not include protocols or protocol amendments submitted only as part of a background package for a meeting with FDA. Protocols are reported in the fiscal year during which they are submitted.
Effectiveness | 0 |
Safety | 4 |
Intended Regulatory Purpose | |
---|---|
To support the demonstration of safety and/or effectiveness for a product not previously approved by FDA | 0 |
To support labeling changes for an approved product, including: | 0 |
0 | |
0 | |
0 | |
0 | |
0 | |
To satisfy a PMR | 2 |
To satisfy a PMC | 2 |
Data Source | |
---|---|
Electronic health records | 0 |
Medical claims | 2 |
Product, disease, or other registry | 2 |
Digital health technologies in non-research settings | 0 |
Other | 0 |
Study Design | |
---|---|
Randomized controlled trial | 0 |
Externally controlled trial | 0 |
Non-interventional (observational) study | 4 |
Other | 0 |
Studies often provide information on both effectiveness and safety. For this report, a study was classified as “safety” if it was conducted primarily to assess a known or potential safety risk. All other studies were classified as “effectiveness.” A study may have more than one regulatory purpose or data source and therefore may be included in more than one category. The term “registry” is sometimes used to refer to a non-interventional cohort study that is intended to address a specific regulatory question in a targeted population. For such studies, this report provides the original source(s) of study data. |
IMAGES
VIDEO
COMMENTS
A research statement is a short document that provides a brief history of your past research experience, the current state of your research, and the future work you intend to complete. The research statement is a common component of a potential candidate's application for post-undergraduate study. This may include applications for graduate ...
The research statement (or statement of research interests) is a common component of academic job applications. It is a summary of your research accomplishments, current work, and future direction and potential of your work. The statement can discuss specific issues such as: The research statement should be technical, but should be intelligible ...
A research statement is a one to three page document that may be required to apply for an . academic job or (less frequently) graduate school. The purpose of a research statement is to describe the trajectory of your research to a selection/search committee. A research statement allows you to • show that you can take on independent research •
A research statement is a short document that provides a brief history of your past research experience, the current state of your research, and the future work you intend to complete. The research statement is a common component of a potential student's application for post-undergraduate study. The research statement is often the primary way ...
How to Write a Research Statement. For a research statement to get its message across, a good format is required, poor formatting may have you lose structure and deliver your points in a disorderly fashion. A great statement should follow the following format: Introduction. As any other academic document, a research statement needs a good ...
5. Tailor your statement to the institution. It is critical in your research statement to mention how you will make use of core facilities or resources at the institution you are applying to. If you need particular research infrastructure to do your work and the institution has it, you should mention that in your statement.
Task #4: Be Succinct. When writing a research statement, many people go on for far too long. Consider three pages a maximum, and aim for two. Use subheadings to help break up the wall of text. You might also embed a well-designed figure or graph, if it will help you make a point.
Writing a Research Statement. A research statement is a statement of purpose for a research related position. The main goal of a research statement is to showcase one's research experience and interest and how they tie in with the position being applied for. Always remember to "Compliment and Complement":
Writing an Effective Research Statement. Published on July 23, 2021. A research statement is a summary of research achievements and a proposal for upcoming research. It often includes both current aims and findings, and future goals. Research statements are usually requested as part of a relevant job application process, and often assist in the ...
Research Statement; Research Statement. Research statements are a frequent component of the academic job market application portfolio and one of the more field-specific documents. In a research statement, you are explaining to the search committee your scholarly profile, research agenda, impact of your work, and how your scholarship fits into ...
This statement is a summary of your research accomplishments, what you are currently working on, and the future direction of your research program. This is also the place to really highlight your potential contributions to your field. For researchers who are further along in their career, this statement may include information about funding ...
What is a research problem statement? As the name suggests, a problem statement (within a research context, at least) is an explicit statement that clearly and concisely articulates the specific research problem your study will address. While your research problem can span over multiple paragraphs, your problem statement should be brief, ideally no longer than one paragraph.
The guidelines are general in nature. Please consult with faculty in your program. regarding conventions in your specific discipline as you start the process of writing the research statement. Also, invite feedback on your statement from colleagues and faculty to ensure that the statement clearly and persuasively communicates your scholarly ...
Writing a research statement happens many times throughout a research career. Often for the first time it happens when applying to Ph.D. programs or applying to fellowships. Later, you will be writing postdoc and faculty applications. These documents are challenging to write because they seek to capture your entire research career in one document that
A research statement lays out your vision of your research, including both your accomplishments to date and your plans for the future. It is a required part of many applications — for graduate school, for fellowships, for jobs (especially academic jobs), for awards, etc.
Research Statements. The research statement is a critical document in academic and research applications, such as postdoctoral fellowships or faculty positions. It is a concise summary of your research background, current research activities, and future research goals. It serves as a tool to showcase the independent research you conduct ...
Writing a Research Statement is a pivotal task for academics and professionals alike. It encapsulates the essence of one's scholarly pursuits, outlining objectives, methodologies, and anticipated outcomes. Crafting a compelling statement necessitates clarity, conciseness, and coherence. As scholars delve into their areas of expertise, they ...
A research statement is usually a single-spaced 1-2 page document that describes your research trajectory as a scholar, highlighting growth: from where you began to where you envision going in the next few years. Ultimately, research productivity, focus and future are the most highly scrutinized in academic faculty appointments, particularly at ...
This document was written to provide some guidance on developing research statements and/or research proposals for funding consideration. The categories below are based on those of the National Cooperative Highway Research Program (NCHRP), but they should be adaptable to any research funding program. Title.
The research statement describes your current research and plans for future research endeavor. While your CV lists facts about your research, your research statement offers the opportunity to expand and provide personal context, such as why you chose this research subject, difficulties and how you resolved them, and why the research is ...
Download Article. 1. Put an executive summary in the first section. Write 1-2 paragraphs that include a summary of your research agenda and its main focus, any publications you have, your plans for future research, and your ultimate career goals. Place these paragraphs at the very beginning of your research statement.
Writing A Research Statement. Ten Tips for Writing a Compelling Research Statement (A non-exhaustive list) 1. Focus on your intellectual interests and professional goals. Although many programs ask for 'personal statements', these are not really meant to be biographies or life stories. What we hope to find out is how well your abilities ...
When applying for a faculty position, a research statement (or summary of research interests) is a document that outlines an applicant's experience, including interests, accomplishments, ongoing research, and future goals. The selection committee uses the document to determine if your interests and experience align with the department, institution, or program. Research is valuable in ...
A problem statement in research is a concise description of an issue that needs to be addressed or a condition that needs improvement. It identifies the gap between the current state and the desired state of a process, product, or situation. The problem statement serves as the foundation for the research study by clearly defining the research ...
See Instruction 2 to Item 1.05 of Form 8-K ("To the extent that the information called for in Item 1.05(a) is not determined or is unavailable at the time of the required filing, the registrant shall include a statement to this effect in the filing and then must file an amendment to its Form 8-K filing under this Item 1.05 containing such information within four business days after the ...
The Securities and Exchange Commission today announced settled charges against two investment advisers, Delphia (USA) Inc. and Global Predictions Inc., for making false and misleading statements about their purported use of artificial intelligence (AI). The firms agreed to settle the SEC's charges and pay $400,000 in total civil penalties.
The new study is thought to be the first to examine how the Texas abortion ban may have impacted infant deaths in the state and is among the first to present evidence evaluating recent abortion bans and pre-viability restrictions. Prior research has shown that states with more abortion restrictions see more infant deaths than those without.
According to a Pew Research Center survey of 8,709 adults - including 7,166 registered voters - conducted April 8-14, 2024: 85% of registered voters who support Biden say that the economic system unfairly favors powerful interests, while just 14% say the system is generally fair to most Americans.
a Studies often provide information on both effectiveness and safety. For this report, a study was classified as "safety" if it was conducted primarily to assess a known or potential safety ...
Our research team looked at Mars because there are plans to send people there. While the atmosphere is toxic at 95% CO₂ (compared to 0.04% on Earth ), Mars has a day length similar to that of Earth.