To assess our progress with results information submission to ClinicalTrials.gov beyond 2020, we conducted analyses of NIH-grant-funded clinical trials for which main results were due in fiscal year (FY) 2020, FY 2021 or FY 2022.
Do you have questions about when it’s allowable to request an extension of the deadline for submitting clinical trial results information to ClinicalTrials.gov, how to request an extension, what to include, and how the requests are evaluated? A recently published resource explains all this and more.
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If you’re conducting research with human subjects, you might have questions about HHS regulations and NIH policies and how you can prepare proposals and inclusion plans. HHS and NIH experts address many of these questions, along with resources, guidance, and case studies in a 2-part webinar series focused on Human Subjects Research Policies, Clinical Trials, and Inclusion.
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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.
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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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