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Continuing to Strengthen Inclusion Reporting on NIH-funded Phase III Trials

Much has been learned about how sex and race may contribute to differences in health outcomes and physiologic conditions (Clayton, 2014). We know that, for example, a specific drug used to treat insomnia requires different dosing for women and men.  African Americans with hypertension are more susceptible to stroke than whites with the same blood pressure levels (Howard, 2013). But in many cases, findings from potentially informative stratified analyses may not be widely available. Less than a third of NIH studies required to analyze sex/gender and race/ethnicity have been found to publish sex-stratified results in peer-reviewed journals (Foulkes, 2011).

Last month, we amended our inclusion policy to enhance the public reporting of these sex/gender and race/ethnicity inclusion data (NOT-OD-18-014). With backing from the 21st Century Cures Act, this amendment specifically requires reporting the results of “valid analyses” on sex/gender and race/ethnicity to ClinicalTrials.gov after completing an applicable NIH-defined Phase III clinical trial.

    • Valid analyses” refers to stratified analyses that explore how well the intervention works among sex/gender and racial/ethnic groups. Though they may or may not be powered studies, they can still shed light on important trends informing the direction for future research questions.
    • Applicable clinical trials, in general, study Food and Drug Administration-regulated therapeutics, biologics, and devices. The reporting requirement we are discussing today pertains to a subset of applicable clinical trials that are also known as “NIH-defined Phase III clinical trials,” which are studies that evaluate an intervention in large groups of people by comparing the intervention to other standard or experimental interventions.  NIH funds approximately 600 of these types of trials each year. 

This reporting requirement applies to new and competing awards made on or after December 13, 2017.  Findings from valid analyses based on sex/gender and race/ethnicity from these applicable NIH-defined Phase III clinical trials must now be reported in ClinicalTrials.gov within one year of completion of data collection for the study’s primary outcome measures. This builds on existing requirements for registering and reporting results in ClinicalTrials.gov. If you have an applicable NIH-defined Phase III clinical trial that was already underway before the effective date, the requirement will not affect you for your current award.

When preparing to register your applicable NIH-defined Phase III trial, we encourage you to identify what outcomes relevant to sex/gender and/or race/ethnicity you will need to report in ClinicalTrials.gov.  Keep in mind that most studies will be expected to report results on sex/gender and race/ethnicity for all primary outcomes.

We are in the process of developing additional guidance, so stay tuned for more to come.

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