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From the content of Diversity Action Plans to the nuances of submission, implementation, and monitoring for inclusive and representative research, there’s lots to unpack here.

FDA Guidance in Context: The April 2022 Draft Guidance and FDORA

For a bit of context on the FDA’s latest clinical trial diversity guidance, it’s helpful first to understand its foundations in the FDA’s Diversity Plans to Improve Enrollment of Participants from Underrepresented Racial and Ethnic Populations in Clinical Trials Draft Guidance and the Food and Drug Omnibus Reform Act (FDORA) of 2022.

  • The April 2022 Draft Guidance for Industry detailed the FDA’s recommendations for industry sponsors to submit race and ethnicity diversity plans prior to the start of pivotal studies, with the goal of more inclusive clinical trials.
  • FDORA called on the FDA to require sponsors of most stage 3 drug and device trials to submit Diversity Action Plans on race and ethnicity, consider additional demographic aspects (such as age, sex, geographic location, and socioeconomic status), host public workshops, issue an annual report on clinical trial diversity, and update the April 2022 Draft Guidance by December 2023.

FDORA represented a significant shift in how industry is held accountable for diversity in clinical trials. 

From FDORA to the Future of Clinical Trial Diversity Plans 

FDORA was signed into law December 2022, with updated guidance expected by the end of 2023.  The FDA missed this deadline, but held its public workshop in association with the Clinical Trials Transformation Initiative on November 29–30, 2023, and put forth additional guidance on collection of race and ethnicity data in January 2024.

The Office of Management and Budget (OMB) also finalized long-awaited updates to Directive 15, including combining race and ethnicity into one question, in March. The FDA issued its annual Drug Trials Snapshot Report in May and published a recap of the Public Workshop in June. And today, finally, the FDA’s updated draft guidance on Diversity Action Plans has arrived – twice the length of the original guidance, with lots to unpack.

While still a draft, the latest guidance incorporates both the comments received on the April 2022 version and the FDA’s experiences with voluntary plans received to date.

Diversity Action Plans Done Right: Takeaways From the Latest Guidance

After months of anxiously awaiting further guidance on the content of diversity plans, this latest draft gives us a clearer picture of what will be required going forward from the FDA.

1. Early and Detailed Plans for Almost All Studies

The prior version of the guidance recommended development of a “Race & Ethnicity Diversity Plan” prior to starting pivotal trials intended for marketing submission, with the initial submission of Diversity Action Plans to occur with IND application, and discussion with FDA to occur no later than end of Phase 2 (for drug products). The latest update reinforces that Diversity Action Plans for drugs should be submitted to the FDA as early as possible (but no later than submission of the Phase 3 protocol) and clarifies how the “action plan” may be updated over time.

While some drug and device studies may not require Diversity Action Plans, the latest guidance clearly states in the updated draft guidance that issuance of waivers will be rare/few and far between. The latest update also adds a focus on diversity of age and sex, as well as consideration of other dimensions of diversity that may impact clinical outcomes, like geographic location and socioeconomic status.

2. The Importance of Context

Per the previous guidance Diversity Action Plans should include an overview of disease in underrepresented racial/ethnic populations in the US, including any differential data/findings.  The guidance released this week elaborates on methodology for setting enrollment goals  (disaggregated by race, ethnicity, sex, and age group) with proper rationale and actionable steps set forth.

The "how" section provides more helpful/detailed recommendations in this guidance than it did in the April 2022 guidance, calling out the importance of sustained community engagement, and collaboration with community partners. There's also a callout for clinical trial site selection in demographically diverse locations, cultural competency training of clinical trial investigators and site staff, streamlining exclusion criteria, reducing participant burden, and implementing decentralized study methods, when possible.

3. Monitoring, Measuring, and Accountability

The previous draft recommended specifying the scope of development program, including expected geographic locations that may address inclusion, as well as goals for enrolling underrepresented populations, based on demographics and background research. To support success and accountability, the plan should include:

  • Detailed operational measures for sustained community engagement
  • Metrics for sustained community engagement
  • Specific plans for post-marketing data collection if initial diversity goals are not met.

The updated guidance builds on this precedent, asking sponsors to submit a description of how they will measure and monitor progress and encouraging prompt intervention if they're off track. It also provides a pathway for submitting modifications to the Diversity Action Plans if a pivot is needed.  For the accountability piece, the updated guidance reinforces annual reporting back to the FDA on how sponsors are tracking toward their diversity enrollment goals.

Finally, the FDA now recommends sponsors publicly post and share their diversity strategies using community-friendly language, and even suggests linking posted goals back to their study recruitment websites or clinical trial information pages, in case patients and members of the public are searching for clinical studies. This emphasis on transparency is key to ensuring diverse communities have increased access and opportunity to get connected to clinical studies.

Your Partner In Inclusive and Representative Clinical Trials

The FDA's recent guidance on clinical trial diversity underscores the critical need for tangible action. At Acclinate, we've spent the past four years at the forefront of this movement, partnering with major pharmaceutical companies to not only achieve compliance, but drive impactful results.

At Acclinate, we leverage a model of affective trust to boost inclusivity in trials faster and for the long term. Unlike traditional recruitment companies, Acclinate utilizes an integrated community platform to help sponsors become leaders in inclusive study design and representative research. For community members, Acclinate’s NOWINCLUDED platform curates accessible health information, trusted connections, high-impact events, and clinical trial opportunities. For sponsors, Acclinate is a unique conduit to reach and mobilize under-represented patient populations, as well as understand and address barriers to their participation in clinical research.

Let's move the needle together. Because it's the right thing to do, and because better science requires better representation. To learn more, schedule a 1:1 Meeting today.

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