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In this episode of the NIH All About Grants podcast, Deysi Duque, a Senior Clinical Trials Analyst within the NIH Office of Extramural Research, talks us through the clinical trials dissemination policy, its purpose, resources (like this decision tree [PDF]), exceptions, and what recipient organizations and researchers should know
NIH’s definition of a Phase III clinical trial is quite broad, including drug studies, device studies, behavioral interventions, epidemiological studies, community trials, and more. Phase III trials are usually large, prospective trails that compare two or more interventions against other standard or experimental interventions.
NIH expects that sex as a biological variable (SABV) will be factored into research designs, analyses, and reporting in pre-clinical and clinical studies. Accounting for SABV helps interpret and validate research findings, as well as enhances the rigor, reproducibility, and applicability of biomedical research. But how exactly do you account for SABV?
Inclusion plans. You have questions. We have answers. NIH’s Inclusion Policy Officer Dawn Corbett covers inclusion plans during peer review and post-award in Part 2 of this NIH All About Grants podcast miniseries. Want to know what is scientifically appropriate as it relates to inclusion, and how reviewers are looking at it? What about the ins and outs on progress reporting? And if you have concerns about enrollment in your funded study, what should you do? Well, as a start, put on your earbuds and listen.
Inclusion plans. You have questions. We have answers. What exactly are they? How do they relate to NIH’s policies requiring specific populations be included in NIH-supported clinical research? What do they mean for your application? And, what is an inclusion table anyway? In Part 1 of this NIH All About Grants podcast miniseries, NIH’s Inclusion Policy Officer Dawn Corbett tells us how to consider inclusion plans when putting together your application.
NIH recently modified the forms used to report enrollment in accordance with the NIH Inclusion Policy. Learn more in our new podcast, “NIH’s Inclusion Policy: Understanding Race and Ethnicity” (mp3 and transcript), and on the NIH Inclusion of Women and Minority website.
For decades, NIH has required valid analysis, also known as stratified analysis, to explore how well interventions work across sex/gender and race/ethnicity for all applicable clinical trials. After revising the policy last year, NIH now requires the findings from these stratified analyses to be reported on ClinicalTrials.gov after an applicable NIH-Defined Phase III clinical trial has completed. Wondering about how this impacts your research?
In this next installment of the NIH’s All About Grants podcast series, we delve into what you should know about certificates (MP3 / Transcript).
The latest NIH All About Grants podcast episode delves into just this issue (MP3 / Transcript). Lyndi Lahl, R.N., an NIH Human Subjects’ Officer, joins us (and her dog too!) in this final episode of this human subjects’ research mini-series.
A new “All About Grants” podcast is now available! In “Understanding the Definition of a Clinical Trial and What That Means for You”, Dr. Mike Lauer, NIH deputy director for extramural research, discusses the changes to clinical trial policies, addresses community questions, and speaks to how these changes will impact applicants and grantees.
