The White House Office of Science and Technology Policy (OSTP) and National Security council recently released a Request for Information seeking ideas on strengthening the national capacity of clinical trial infrastructure and emergency clinical trials.
The Project Outcomes section of the Research Performance Progress Report (RPPR) provides information about the cumulative outcomes or findings of the project. This information is made available to the public through NIH RePORTER, so take that into account when completing this section!
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NIH supports Phase III trials to study how effective interventions are in large groups of people, comparing them to other standard or experimental interventions. We go deeper into these clinical trials and what you should know in our next edition of the NIH All About Grants podcast.
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We have been busy over the past several months and are happy to announce you can now find helpful resources for stepped wedge group-or cluster-randomized trials (SWGRTs) and more than 15 other study designs and methodological issues on the RMR website.
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NIH-defined phase 3 clinical trials are required to conduct and report analyses by sex or gender, race, and ethnicity for each primary outcome. These analyses, referred to as “valid analyses” are unbiased assessments that on average, yield the correct estimate of the difference in outcomes between two groups of participants.
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NIH uses sex/gender to indicate that either sex or gender may be reported for inclusion enrollment purposes. The NIH encourages investigators to design their data collection instruments in a way that allows the participants to self-identify their sex or gender in a way that is meaningful within the study’s context. Participants always have the option not to identify with either sex/gender category. If both sex and gender identity are collected, investigators may choose which one to report based on the scientific question(s) that are the focus of the study.
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Yes. If only one aim or a small part of your project meets the NIH definition of a clinical trial, your entire NIH grant application is considered a clinical trial even if the other aims or parts of the research project are not clinical trials.
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Basic Experimental Studies Involving Humans (BESH) are studies that meet both the federal definition of basic research and the NIH definition of a clinical trial. Looking for more information about what studies fall within the BESH definition and what policies apply? Our latest NIH All About Grants podcast episode will answer these questions and more!
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We have embarked on a series of initiatives at NIH in recent years to enhance the quality, efficiency, accountability, and transparency of our supported clinical research. While we are all making great progress, our concerns about clinical trials that are overly complex, have small sample sizes, or rely on surrogate end points that lack clinical relevance remain. One resource to help address these concerns is the NIH Research Methods Resources website that NIH’s Office of Disease Prevention (ODP) launched in 2017. Since the site was recently revamped, we wanted to spotlight the new available tools and resources that can help you better plan the design, conduct, and analysis of rigorous NIH-defined clinical trials.
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The FDA recently released two new tools that were developed for investigators and clinicians: 1) Research IND Pilot Portal and 2) Expanded Access eRequest.
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