isalignment on diversity in clinical trials continues. Some sponsors have proactively implemented Diversity Action Plans for their clinical programs ahead of FDA requirements, for example, while other sponsors choose to wait until firm requirements are in place. Even during implementation, some team members find diversity or representation critical; some don’t find it necessary; still others consider diversity a nice gesture but don’t prioritize it.

Although the FDA guidance on enhancing the diversity of clinical trial populations has been final since December 2020, there has been slow movement towards implementation, perhaps because they are guidelines and not requirements. Separately, before the FDA released updated draft guidance on Diversity Action Plans (DAPs) in June 2024, there were varied interpretations. The updated draft clarifies that DAPs will be required for pivotal drug protocols that begin enrolling, and Investigational Device Exemption applications that are submitted, 180 days following the publishing of the final guidance. A grace period is also defined. Some organizations may take this as a reason to pause diversity efforts. However, diversity “planning” can and should still occur. There are benefits to implementing these strategies throughout the drug development process.

Clinical trial populations should represent the populations who will use the product if (when) the product is approved. Trial participants should represent the population with the disease or condition. Although the DAP documents efforts to ensure representative clinical trials, the planning and strategies that go into the DAP are critical. When planning begins in early phase 1 and 2 studies or pharmacology studies, it reinforces the sponsor’s commitment to enrolling representative trials. Also, since sponsors may reuse the same sites, implementing strategies in early phases sets expectations for later trials. This, in turn, can help make writing the DAP easier because sponsors will have already tested different strategies, determined which worked, and can decide which to use again. In addition, study start up for later trials can also be streamlined as sponsors will have vetted vendors from early trials, which saves on qualification and contract timelines.

It benefits sponsors to enroll a population that represents those who will use the product when approved. Sponsors can understand how the product works in all populations. Through resources like FDA Drug Trials Snapshots, potential patients and healthcare providers can check whether a product was tested on individuals with similar demographics to their own. Rather than seeing diversity planning as separate and optional efforts, sponsors can easily incorporate these activities into routine study execution tasks now, from protocol concept through study start up, enrollment, maintenance, and closeout. This can include the following:

• Utilize a diverse steering committee to review the protocol
• Consider underrepresented populations when writing exclusion criteria
• Engage with patient advocates and the patient community when designing the protocol visits and procedures
• Add language in the protocol highlighting the importance of representative trials
• Consider a decentralized design, or rural and less experienced sites with diverse populations
• Ask site feasibility questions to understand site process on enrolling diverse participants
• Coordinate travel and housing for participants and caregivers or advocates if necessary
• Translate participant-facing materials into local community languages.

For clinical trials with a DAP, sponsors should share sufficient detail with vendors and sites since they are clinical trial partners working towards the same goals. Vendors and sites should proactively ask sponsors if there is a DAP for a particular trial and ask sponsors for details. Each sponsor team can determine how much detail of the DAP to share. At a minimum, sponsors should communicate the desire to enroll a representative trial, and any important details vendors and sites should know. For example, if more Japanese participants are needed to adequately study the population in a certain disease, sponsors need to inform vendors and sites of this. Although sponsors and sites partner together in diversity efforts, the sponsor is accountable for the goals in the DAP and drives and provides oversight of this work.

Separate from FDA guidance, some publications already have diversity requirements. As of January 2022, The New England Journal of Medicine requests authors provide a Table of Representativeness of Study Participants which includes a description of the disease or condition, who has the disease or condition, and a summary of the overall representativeness of the clinical trial. Therefore, sponsors who have already implemented diversity strategies and enrolled a representative clinical trial will have an advantage when seeking publication.

Let’s shift our mindset from needing “clinical trial diversity” to boldly aiming for “representative clinical trials.” This trend will continue globally as other health authorities such as Health Canada and MHRA have publicized their efforts in enrolling underrepresented populations. It is our responsibility within the life science ecosystem to act now, recognizing that this shift will ultimately benefit everyone involved. Together, we can create a future where clinical research truly reflects the world we live in.