Diversity in Clinical Trials: The Latest FDA Guidance

Diversity has always mattered in clinical trials. As the National Institutes of Health (NIH) notes, “people may experience the same disease differently.” With a more diverse pool of clinical trial participants, researchers can better account for these differences and support medical advancements that benefit the broader population.

For almost 10 years, diversity in clinical trials has been a hot topic; now, it’s inching closer to being a mandate. Seeing the ongoing underrepresentation of minority demographics in clinical trials, the Food and Drug Administration (FDA) has taken steps to close health equity gaps.

As FDA guidance on diversity in clinical trials continues to evolve, we’re providing an overview of where things stand today.

The FDA’s Current Guidance on Diversity in Clinical Trials

In October 2016, the FDA issued a guidance document on the collection of race and ethnicity data in clinical trials. This non-binding recommendation encouraged clinical trial sponsors and sites to start systematically planning for better inclusion of diverse participants. That included submitting a plan to address the inclusion of clinically relevant subpopulations for drugs and biologics. As the FDA notes, “inadequate participation and/or data analyses from clinically relevant subpopulations can lead to insufficient information pertaining to medical product safety and effectiveness for product labeling.”

Fast forward to April 2022, when the FDA expanded upon its original guidance in a 12-page document. The new guidance provided recommendations on what sponsors should include in a Race and Ethnic Diversity Plan to outline their strategies for enrolling and retaining a diverse clinical trial. Examples include:

• An overview of the trial’s disease/condition of focus, with any available data on its prevalence across underrepresented racial and ethnic populations
• The scope of the clinical trial, from study design and study population to endpoints and expected geographic locations
• Enrollment goals for underrepresented racial and ethnic populations, as based on disease epidemiology and/or a priori knowledge that affects outcomes across racial and ethnic groups
• A plan of action to enroll and retain diverse participants, including strategies to support site location and access, community engagement, and reducing burdens
• Defined metrics to meet enrollment goals, alongside actions sponsors will take if planned clinical trial enrollment goals aren’t met
• A plan and justification for data collection in a post-marketing environment if enrollment goals can’t be met, despite the sponsor’s best efforts

Alongside these recommendations, the document also made note of two legislative proposals: the Diverse and Equitable Participation in Clinical Trials (DEPICT) Act and the Diversifying Investigations Via Equitable Research Studies for Everyone (DIVERSE) Trials Act.

The Shift From Trial Diversity Recommendations to Legislation

These pieces of legislation would mandate diversity plans from clinical trial sponsors. These plans would include enrollment targets broken down by age group, sex, race, and ethnicity and strategies for meeting these targets. In the event that sponsors did not meet diversity enrollment targets, the FDA would have the authority, in some cases, to require further studies or surveillance after medical drug or device approval.

In light of this legislation, failure to adequately represent diverse populations in clinical trials would leave sponsors with financial burdens. While dedicating more time and resources toward research, there’s also protracted time-to-market. Delays in drug or device approval translate into longer periods without revenue, which can cost hundreds of thousands to millions of dollars per day.

Preparing for New Clinical Trial Diversity Standards

With diversity in clinical trials positioned to become law, now is the time for drug and medical device companies to establish more inclusive processes. On the one hand, study protocols should be designed in collaboration with community stakeholders and provide a degree of accessibility that reduces the burden of participation. At the same time, there must be targeted recruitment and retention efforts to sustain participation.

Research shows that 80% of delays in clinical trial timelines are caused by patient recruitment and retention. With the need to enroll a more representative participant pool, enrollment and engagement can become even more complex and labor intensive.

At Remington-Davis, we have a proven track record of supporting customers with rapid study subject enrollment. With almost 16,000 volunteers in our database, we can help get clinical trials that meet current diversity standards up and running faster. We’re proud to have a 35% patient diversity rate. And with a 98% patient retention rate, you can be confident in our ability to keep patients engaged. 

Learn more about the support we can provide as a clinical site provider. Contact us for additional information.