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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
ClinicalTrials.gov is the world’s largest repository of clinical trial information. The site allows the public to easily find and learn about the myriad of research studies in human participants. Users can determine which studies are recruiting, when they will be completed, and can even find trial results. But what should researchers and recipients be aware of regarding this system as it relates to reporting NIH grant-funded trials?
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. 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.
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?
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.
Starting January 29, 2019, NIH will begin implementing the Inclusion Across the Lifespan policy, which requires the consideration of age, along with sex/gender and race/ethnicity, in applications that involve human participants. What does this policy mean for you and your study?
You’ve done your homework: read the requisite materials on human subjects, spoken with program staff at NIH, even listened to Part 1 of this podcast mini-series for some insights on how you know you are actually doing human subjects research. Now you’re ready to explain in your NIH grant application how research participants will be protected and monitored.
Basic Experimental Studies Involving Humans (BESH) are studies that meet both the federal definition of
