June 2024 Guidance on Diversity Action Plans: Continuing to Build DE&I Momentum

By Catherine Gregor

In case you missed it, the FDA handed down a new draft guidance last month that mandates diversity metrics be part of the study plan for all device studies and phase III drug studies. This guidance is a direct response to the 2022 FDA Omnibus Reform Act (FDORA) which issued a call to action to the FDA to move diversity planning from a recommendation to a requirement. Specifically, FDORA requires the FDA to start publicly reporting diversity metrics in 2024.

Enter the June 2024 Diversity Action Plans to Improve Enrollment of Participants from Underrepresented Populations in Clinical Studies Guidance for Industry. This latest guidance attempts to provide insight into both the what and the how of diversity metrics reporting with several key points:

Here’s what’s controllable:

1. Mandatory Diversity Metrics: The 2024 update introduces mandatory metrics for diversity that sponsors must achieve. These metrics are aimed at ensuring a quantifiable representation of underrepresented groups in clinical trials.
2. Expanded Community Partnerships: The guidance now includes more detailed requirements for community partnerships, emphasizing long-term engagement with local health organizations and advocacy groups to foster trust and improve participation rates.
3. Technological Integration: The 2024 updates encourage the use of technology to facilitate remote participation in trials, making it easier for individuals in underserved areas to participate without the need for frequent travel to major medical centers.
4. Enhanced Reporting and Transparency: Sponsors are now required to provide detailed reports on their progress toward diversity goals, including any challenges faced and strategies implemented to overcome them. This increased transparency is designed to hold sponsors accountable and share best practices across the industry.

To fully comply with the FDA’s recommendations and achieve the desired impact, sponsors and sites will need to implement several operational changes:

1. Flexible and Inclusive Protocols: Sponsors will need to revise clinical trial protocols to be more flexible and inclusive. Including reassessing eligibility criteria to avoid unnecessary exclusions and considering the practical challenges faced by participants, like travel and time commitments.
2. Resource Allocation: Sites and sponsors, both, will need to allocate more resources to support participants from diverse backgrounds. This may include providing transportation, childcare, and financial assistance to remove socioeconomic barriers to participation, which will put additional demands on study teams and budgets.
3. Training and Education: The industry as a whole needs to conduct regular training sessions for clinical trial staff on cultural competency and the importance of diversity in clinical research. This training should emphasize the ethical and scientific reasons for inclusive trials and provide practical strategies for achieving them.
4. Use of Technology: Sites and sponsors will need to leverage technology to facilitate remote participation in clinical trials. This includes using telehealth for consultations, electronic data collection tools, mobile health applications to reduce the need for frequent in-person visits, and remote monitoring to maintain oversight across multiple locations at once.
5. Robust Data Collection and Reporting: Sponsors will need to implement systems for rigorous data collection and reporting on diversity metrics. Sponsors should track and publicly report on their progress toward achieving diversity goals, including any barriers encountered and how they were addressed.
6. Sustainable Partnerships: Sponsors and Sites will need to get creative about how to foster long-term partnerships with community organizations and local healthcare providers. These partnerships should go beyond individual trials and aim to build a sustainable infrastructure for ongoing community engagement and participation in clinical research.

While none of these recommendations are entirely new, the new guidance provides the incentives necessary for sponsors and sites to move from deliberation to action. This will not only improve the quality and applicability of clinical trial data but also ensure that all populations benefit equitably from advancements in medical science.

Check out the Florence Library of FDA Guidance for more information to help you understand and apply the FDA’s guidance for clinical trials.