FDA Issues New Draft Guidance on Diversity

Posted in Process Improvement

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The FDA issued draft guidance on April 13, 2022, on Diversity Plans to Improve Enrollment of Participants from Under-represented Racial and Ethnic Populations in Clinical Trials.

They acknowledge that the lack of representation reflects, in part, a broader issue regarding differential access to healthcare as well as a mistrust of the clinical research system stemming from historical events such as the unethical Tuskegee experiments. COVID-19 highlighted the lack of access for under-served populations and is serving as a catalyst for change.


This follows the introduction of the Diverse and Equitable Participation in Clinical Trials (DEPICT) Act to Congress on Feb 3rd, legislation with bipartisan support aimed at boosting diversity in clinical trials by requiring enhanced data reporting on clinical trial demographics and providing resources to improve access to clinical trials.

When it becomes law, IND and IDE applicants will be required to report clinical trial enrollment targets by demographic subgroup including age, race, ethnicity, and sex and provide a rationale for those targets. It will also require sponsors to provide a Diversity Action Plan detailing the actions sponsors will take, such as outreach and engagement strategies, to reach these enrollment targets.

The DEPICT Act will also provide the FDA with the authority to mandate post-marketing studies when sponsors fail to meet diversity enrollment targets and do not provide sufficient justification.

How does New FDA Guidance differ from the guidance on Enhancing Diversity released in November 2020?

The new guidance has more specificity on what the agency expects. It encourages sponsors to develop and submit a Race and Ethnicity Diversity Plan as soon as practicable during medical product development but no later than when a sponsor is seeking feedback regarding the applicable pivotal trial for the drug (often during the end of Phase 2 meeting).

Specifically, they recommend that the plan detail the operational measures that will be implemented to enroll and retain underrepresented racial and ethnic participants in the planned trials, and the planned use of data to characterize safety, efficacy, and optimal dosage in these participants, when applicable.

The plan should describe specific trial enrollment and retention strategies including but not limited to:

  1. Site location and access (e.g., language assistance for persons with limited English, reasonable modifications for persons with disabilities and other issues such as transportation)
  2. Sustained community engagement (e.g., patient advocacy groups, community advisory boards and patient navigators, local healthcare providers, etc.)
  3. Reducing burdens due to trial/study design/conduct (e.g., number/frequency of study related procedures, use of local labs, telehealth, etc.)

The plan should also describe the metrics that will be used to ensure that diverse participant enrollment goals are achieved and the actions that will be taken during the trial if the enrollment goals are not being made.

There can be no doubt that FDA is serious about ensuring representative numbers of participants from underrepresented racial and ethnic populations are enrolled in clinical trials so they can better reflect the population most likely to use the drug or device, if approved. The WCG Avoca Quality Consortium (AQC) has a workgroup focusing on Patient Diversity Metrics Development as well as tools for monitoring diversity during clinical trial conduct.

AQC Members can access RBQM 11, Site Diversity Workbook, a tool created to support sponsors and investigators in assessing the success of their efforts to recruit a diverse population. It can be used for insight to optimize organizational spending, improve diverse recruitment efforts, help reach patient diversification goals and to evaluate the impact on your clinical trial.

Learn more about becoming a Member of the AQC to access over 1,000 leading practices and metrics to help your organization be prepared.
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Another pressing question is what the barriers might be to participation. That will require a study or program specific approach to raise awareness about the trials, educate sites and investigators, build relationships with patient advocacy groups, seek input on the trial design, provide flexibility in visit options including transportation and childcare, and ask patients what would ease the burden of participation. WCG has been working in this area for years and has developed a framework and tools to help sponsors, including identifying sites willing and able to enroll the mix of patients required for your trial. Contact us to learn more.


Brigid Flanagan, BA, RN, CCRC, MSB

Senior Consultant

WCG Avoca