The FDA’s recently released draft guidance on diversity action plans for clinical trials has brought renewed focus on increasing the representation of underrepresented populations in clinical trials. The plan aims to address long-standing disparities in health outcomes and ensure that new treatments are tested adequately within diverse communities. BDO hosted a virtual town hall discussing what the new FDA guidance means for clinical trials and getting Black Americans the medicine they need.
What exactly is in this FDA draft guidance?
Dr. Randall Morgan, Jr., executive director at the Cobb Institute explains the main objectives of the plan: “The action plan is a very important element that the FDA has just introduced in follow-up to the FDORA Act of 2022. This is sort of the second foot, the implementation,” Dr. Morgan tells BDO’s executive editor Jade Curtis. “And it focuses upon enrollment increase and increase in participation of historically underrepresented populations in clinical trials.”
One key aspect that sets this plan apart from previous diversity initiatives is its emphasis on community engagement strategies. Jeanne Regnante, CEO and founder of Patient 3i, as well as a patient advocate for the Tigerlily Foundation, notes, “Community engagement strategies are much more pronounced in the new diversity action plan. And this is captured, specifically under measures to meet enrollment and retention strategies.”
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The plan recommends engaging with patient organizations, navigators, community-based organizations, and faith-based groups to build trust and facilitate participation. It also emphasizes the need for cultural competency training for clinical investigators and their staff, as well as measures to reduce biased communication and expand eligibility criteria.
Why is this FDA guidance important?
Elaine Palmer, director of clinical operations at Pivotal Clinical Research, highlights the importance of this plan from a clinical research site perspective: “So for sites, certainly, we’re looking forward to collaborating with the sponsors and the CROs…in terms of the making sure the [stipulations] align with the expectations.”
While the plan guides various aspects of community engagement and inclusive trial design, there is still room for improvement. Palmer suggests providing a suggested range for diverse participant representation in clinical trials to ensure meaningful representation.
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This sentiment is echoed by the other panelists, noting the need for clarity on how representation should be calculated, whether based on prevalence or incidence rates for the disease under study.
How can pharma companies approach meeting these requirements?
Beyond the plan’s specifics, the panelists emphasized the need for a fundamental shift in mindset and approach to overcome historical distrust and barriers to participation among underrepresented communities.
Regnante advocates for a community-centric approach, stating, “We need to focus on what works… We need to ask the patient for their experience before, during, and after clinical trials. For example, if the participant partners that we work to engage in a clinical trial feel they’re not respected or they feel that bias has been placed on them, then the sponsor shouldn’t use that site.”
Dr. Morgan emphasizes the importance of building relationships and giving back to the community before seeking participation in clinical trials. He suggests sharing trial results with participants to foster trust and transparency.
Regnante sums it up aptly: “It’s not health equity until the patient says so. And, we also need to be very deliberate in leaving something meaningful behind when we conduct a clinical study in the community and thank people for their contribution to science.”
As the conversation concludes, there is a collective recognition that achieving true health equity and inclusive representation in clinical trials will require a sustained, collaborative effort involving sponsors, CROs, research sites, and most importantly, the communities themselves.
This new FDA guidance is a crucial step forward, but it is only the beginning of a journey toward a more equitable and inclusive health care ecosystem. By prioritizing community engagement, cultural competency, and patient-centricity, the industry can work towards developing treatments that truly serve the needs of all populations.
