Implications of regulatory and FDA guidance on diversity, equity, and inclusion on clinical research study sites

It is well established that focusing on diversity in clinical trials is essential for developing therapies that are safe and effective for different patient populations. But are clinical research study sites implementing regulatory guidelines on diversity, equity, and inclusivity? How can we ensure study enrolment is representative of the expansive patient populations who will need a particular treatment or diagnostic?

The 2023 Society for Clinical Research Sites (SCRS) Global Site Solutions Summit organised a panel to discuss key perspectives on enhancing diversity in clinical trials and improving the industry’s understanding of the regulatory guidance on this matter. The panel “Regulatory and FDA guidance on Diversity, Equity and Inclusion: What sites and industry need to know” was facilitated by Dr Diana Foster, CEO of Total Diversity Clinical Trials, and I had the opportunity to provide the site perspective, alongside Korin Martin, MS, director, project management office at Merck, and Tony Pearson, JD, MPH, senior director, diversity and clinical trials at Lilly. The session was well attended and covered the following topics:

• Understanding the April 2022 FDA Guidance on diversity in clinical trials: The panel provided a detailed explanation of the guidelines and discussed how adherence to the guidance has been increasingly expected for regulatory submissions. The objective of this was to provide attendees with an understand of the regulations governing a sponsor and site plans, as well as how it has been impacting sites even in the absence of any documented guidance prior to April 2022.
• Impact of the guidance on recruitment and retention requirements: The panel discussed the impact of the new guidance, with a focus on diverse recruitment and retention, and the impact of required sponsor action plans on delivering diversified enrolment to all studies phase 2 and beyond.
• Action plans: Examined the best way to implement actions plans for sponsors and sites, as required by the new guidance. Having diversity action plans that are far-sighted and compound over time to build stronger relationships with the patient community.

Diversity and inclusion from a site perspective

It was discussed how critical it is for sites to implement these guidelines on diversity, stressing the benefits of clinical trial sites that are reflective of a broader patient population to minimise any disparities that might arise in terms of treatment opportunities if a certain demographic is left underrepresented, including the following key points:

The power of ‘one’: Even one patient in a representative sub-population can make a difference in a trial. If every site enrolled one diverse patient, it could impact the outcome of a study. It is important to note that diversity not only signifies ethnic or racial paradigms, but also poverty status, sexuality, and other social determinants of health.

Establishing necessity: The diversity in site planning is no longer a “nice to have”, but a “need to have”. A diverse study population is often essential for obtaining regulatory approval and funding, but, more importantly, it can expand the use of a treatment and improve its efficacy.

Understanding variability: Study teams need to understand the importance of diversity in site enrolment. This discussion included a case study that demonstrated reduced metabolism in Asian participants in contrast to other ethnic groups. This is hugely impactful, not only for getting new medications and treatments approved for the patients who need them, but also at the right dosage and medication schedule.

Site representation: Patient diversity will improve only when it is approached from all angles. Successful diversified patient enrolment will not be achieved solely based on advertising alone, but through diversity of site staff and fostering meaningful relationships with local diverse communities.

Geographic considerations: Choosing a diverse location for a site will not ensure diverse enrolment. Sponsors and sites must engage and build trust with the community around the site location. Optimising the geographic advantages as well as relationships are both equally pertinent.

Budgetary parameters: To improve representative diversity, there must be a robust action plan that can justify and attract more funding from sponsors for diversity recruitment and retention initiatives. Tracking data from prior trials that supports the success of your action plans will yield better sponsor-approved budgetary allotments.

Conclusion

The panel emphasised the need to translate the theoretical material on regulatory guidelines into actionable implementation plans from all perspective’s - patients, and sponsors to site. Diversity has been a top priority in clinical research for some time, but understanding its implications and ideating site planning based on these rules was a unique approach for this panel. The focus was on understanding the need for modifying site solutions, so they are indicative of the implementation of the new guidelines. There was consensus on the need for strong partnerships and communication between sites and sponsors for a more inclusive study environment that benefits patients.