The FDA’s draft guidance on Diversity Action Plans brings a renewed focus and attention to initiatives that will assist in recruiting more diverse populations in clinical research studies. Its final guidance is anticipated to be released this year. Including populations in research who are most likely to use the study drug or device once it’s on the market can lead to more effective treatments and a better understanding of potential adverse events. This guidance will increase the confidence of those healthcare providers prescribing the newly approved products.
The draft guidance may prompt stakeholders to implement solutions from various angles, but they could overlook the most crucial aspect. Focusing solely on numerical targets for diversity action plans rather than addressing the human element involved in recruiting diverse populations misses the broader objective. A concerted effort is required within communities to raise awareness of clinical research, the sites conducting that research, and the sponsors involved. This effort can increase trust in the clinical research process in more communities, thereby recruiting more participants from more diverse backgrounds. It is also crucial to treat every potential participant with respect and dignity. This includes fully informing them about the studies for which they are eligible and emphasizing the benefits for the participants, not just for the sponsor or site.
On-site study interactions are also critical. According to the Tufts Center for Drug Development Impact Report issued in November/December 2024, discriminatory behaviors from study staff harm trust and patient enrollment diversity. Tufts reported that potential participants of color who cite that study staff devalue their pain or medical symptoms or display impatience when asked about medical procedures are less trusting of study outcomes and less willing to participate in future trials.
A recent Research America National Survey on Clinical Trials found that while 49% of those surveyed were willing to participate in a clinical trial, only 26% reported that they or someone in their family has actually participated. Additionally, the top reasons for not wanting to participate included distrust, adverse side effects, and lack of awareness or information. If the clinical research industry can come together to alleviate the distrust and inform potential participants about the clinical research process, it can increase the number and diversity of study participants globally. While the trust-building phase allows a minimal margin for error, the effort yields significant rewards: improved treatments for everyone.
