The FDA has made it clear sponsors should start now to develop diversity action plans with the help not only of guidance released last year but also the promise of more guidance to come and the offer of consultation with the agency itself.

The FDA recognizes that trial diversity may be an unfamiliar endeavor for many sponsors, including a growing number of biotech companies developing therapies for rare diseases and other genetic diseases that aren’t accustomed to working closely with the agency, Steve Smith, WCG Clinical’s president of patient advocacy, told attendees last week during WCG’s second webinar in its Participant Playbook series (CenterWatch Weekly, March 20).

“The FDA specifically said … we realize this is a new area, this diversification of clinical trials,” Smith said. The agency wants to collaborate with sponsors to work out plans for their individual trials “because it’s new for you and it’s new for them.”

“Connect early in your trial planning with the FDA and ask them to look at your plans,” he advised. “Ask them to help you when you’re stuck with a diversity action plan.”

The agency has clearly signaled its support, with top agency officials, including Commissioner Robert Califf, directing sponsors to devote attention to diversity action plans now, stressing the priority the agency is placing on enabling the development of drugs that are appropriate for their intended populations, Smith said.

And Congress has supported the agency’s emphasis, passing the Diverse and Equitable Participation in Clinical Trials (DEPICT) Act last year to mandate diversity action plans for pivotal trials (CenterWatch Weekly, Jan. 2).

The FDA plans to issue new draft guidance by December, Smith said, spelling out the expected format and content for these strategies. But there’s no reason to wait for the guidance to come out, considering the priority the agency is placing on trial participant diversity. Initial guidance the agency published in April 2022 is a good place to start planning, he advised (CenterWatch Weekly, April 18, 2022).

The agency will also convene public workshops for stakeholders to discuss and comment on diversity action plans prior to the issuance of the final guidance. And it will be required to submit annual diversity reports to Congress to track the progress of diversifying clinical trials “starting in 2025 or sooner,” Smith said.

Smith also noted that the agency recognizes not all pivotal trials will be able to realistically enroll diverse populations, such as those for diseases specific to or prevalent in a particular population, or in public health emergencies where time is critical. For situations like these, it will grant waivers.

Though the final guidance isn’t out yet, sponsors can gauge what information the agency is likely to expect in diversity plans from the legislation itself. Smith says that the FDA will likely call for diversity plans to contain:

• Goals for trial enrollment categorized by age group, sex and racial/ethnic characteristics;
• Rationale for these enrollment goals, including information on the disease and its prevalence in certain groups and various demographics; and
• How the goals will be met, including demographic outreach strategies, enrollment plans, inclusion/exclusion practices, and plans for training trial staff on diversity.

“This is going to be something which more and more companies will understand,” Smith said. “It will become more standard [and] it won’t be so mysterious for anybody who today wonders about it.”

Access the Participant Playbook webinar series here: https://bit.ly/3KlqJVi.