FDA Issues Diversity Action Plan Draft Guidance
The US Food and Drug Administration (FDA) has issued a preliminary guideline advocating for more diverse patient groups in clinical trials. This initiative aims to enhance the quality of data submitted in support of premarket applications. The guideline outlines aspects that sponsors should include in their Diversity Action Plans as directed by Congress. Download guidance here.
In the recently released draft guidance, the FDA specifies the content of a sponsor’s Diversity Action Plan, identifies the products that necessitate these plans, and outlines the submission process to the agency. Once finalized, this guideline will supersede the FDA’s 2022 directive regarding diversity plans in clinical trials.
Specifically, the Diversity Action Plan must include the sponsor’s rationale and patient enrollment goals based on age, ethnicity, sex, and race. It also urges sponsors to look beyond those factors to other demographic differences and consider how they may affect the product’s performance.
Based on the guidance: “Diversity Action Plans are intended to increase enrollment of participants who are members of historically underrepresented populations in clinical studies to help improve the strength and generalizability of the evidence for the intended use population. Such plans must specify ‘the sponsor’s goals for enrollment in [a] clinical study,’ ‘the sponsor’s rationale for such goals,’ and include ‘an explanation of how the sponsor intends to meet those goals.’”
“In general, clinical study diversity helps ensure that clinical studies appropriately test the product in a representative sample of the product’s intended use population. Factors to consider when setting enrollment goals include demographic characteristics (e.g., race, ethnicity, sex, age group), clinical characteristics (e.g., presence of comorbidities, disease etiology), and other characteristics (e.g., access to standard preventive and diagnostic care, access to standard treatments of the clinically relevant population).” (Regulatory Focus RAPS.org)
Miller Tanner Associates’ Commitment to Clinical Trial Diversity and Equity
Miller Tanner Associates (MTA) has recently joined Trial Equity in a partnership aimed at expanding education and participation across diverse patient groups, a strategic move to address the crucial gap in clinical trial diversity. This collaboration will co-market Trial Equity’s innovative Clinical Trial Diversity Training to pharmaceutical sponsors, CROs, and site networks, leveraging MTA’s extensive global reach and expertise in event management within the healthcare sector.
“This partnership marks a critical step toward ensuring future medical breakthroughs are effective and accessible to everyone, truly reflecting the diverse communities we aim to serve,” shared Trial Equity Co-Founder Dr. Otis Johnson.
This partnership anticipates transforming clinical trials through:
- Enhanced Recruitment and Retention: Empowering study staff with the tools to recruit and retain minority participants more effectively.
- Increased Compliance and Generalizability: Ensuring that trial findings are more reflective of the population, adhering to FDA and EMA guidelines on diversity.
- Innovative Learning Solutions: Delivering engaging and interactive training modules that include video lectures, activities, games, and case studies, with a certificate of completion for sites’ Trial Master File, upon passing the included assessment.
Together, Trial Equity and Miller Tanner Associates are setting new standards in clinical trial diversity, paving the way for a future where medical research is truly inclusive. To learn more about this partnership, click here.
For more information on the Clinical Trial Diversity eLearning Course, or to arrange a diversity workshop, please visit Miller Tanner Associates or Trial Equity.
