PRIM&R Responds to FDA’s Draft Guidance on Enhancing the Diversity of Clinical Trial Populations

PRIM&R Responds to FDA’s Draft Guidance on Enhancing the Diversity of Clinical Trial Populations

August 2, 2019

Boston, MA— In June, the Food and Drug Administration (FDA) issued a draft guidance, "Enhancing the Diversity of Clinical Trial Populations—Eligibility Criteria, Enrollment Practices, and Trial Designs." The issuance of this guidance satisfies a mandate of the FDA Reauthorization Act of 2017 (FDARA), and builds on other recent efforts by the FDA to broaden eligibility criteria for clinical trials and avoid unnecessary exclusions. PRIM&R submitted comments on the guidance this week.

In our comments, we recognize that the draft guidance represents a significant and welcome step forward in the agency’s efforts to enhance diversity in clinical trial participation and applaud the FDA’s leadership in recommending a wide range of practical strategies that sponsors and other parties can adopt to advance this important goal.

However, we urge the FDA to include in the draft guidance a more robust discussion of the ethics of enhancing clinical trial diversity. In the current version of the guidance, the rationale for enhancing diversity in trial enrollment is presented almost exclusively as a matter of better reflecting the populations most likely to use the study therapy if approved. We point out that there are also ethical reasons to widen eligibility criteria and make other efforts to include populations that might otherwise be underrepresented in trials.

We urge the FDA, furthermore, to make clearer and help stakeholders understand that the inclusion in clinical trials of previously underrepresented groups may involve ethical tradeoffs. Making a commitment to diversifying trial enrollment and including previously underrepresented groups in research—including those with comorbidities—requires explicitly acknowledging the possibility of heightened risk and implementing appropriate safeguards.

Finally, we make a few additional recommendations, including that the guidance incorporate non-English speakers in its list of populations that are often excluded from clinical trials without scientific rationale, as they can be safely enrolled in research provided certain safeguards are put in place. The FDA should also consider extending the guidance beyond drugs and biologics to include devices.

Download PRIM&R's Full Response

Press Release

PRIM&R Responds to FDA’s Draft Guidance on Enhancing the Diversity of Clinical Trial Populations

About PRIM&R

Media Contact: