Diverse Enrollment — Ahem, "Biological Variability" — Gets Widespread Support At RAPS Convergence
By Abby Proch, executive editor, Clinical Leader
What is with acronyms lately? Mention AI, and you get an eyeroll. Talk about DCTs, and people begin fiddling with their phones. Bring up DEI, and they fidget in their seats.
The fidgeting at the mention of diversity initiatives here and across industries, happens for different reasons, which run the gamut from “It’s a bunch of bull” to “Ooh, don’t say that too loudly” to “Let me grab the mic ’cause this conversation ain’t over.”
At RAPS Convergence 2025, the reasoning fell strictly in the third category, both on the stage and in the seats for the panel discussion, “Enhancing of Biologic Variability Through Representation in Clinical Trials.” Roughly translated: We need diverse clinical trial participants to help develop drugs that are safe and efficacious for their intended users.
Since this is a regulatory conference, panelists quickly pointed to the yo-yo publishing of the FDA guidance on diversity action plans (DAPs). You’ll recall that earlier this year the agency published the draft guidance under the Biden Administration, then removed it under the Trump team, then put it back online after a court order — but with a warning of sorts and the claim, “This page does not reflect reality and therefore the Administration and this Department reject it.” And now, we’re in limbo as we await its fate.
Despite DAPs’ purgatorial existence, the assembled group representing pharma, CROs, technology providers, and patient advocacy agreed that sponsors should still incorporate patients early in the drug development process, prioritize biologically variable (AKA diverse) participant enrollment, and document those efforts as if DAPs were already approved. After all, “good science” necessitates it, and government administrations do change, said panelist Sarah Bentouati, PharmD, MSc, of F. Hoffman-La Roche.
Part of enrolling the right and sufficiently diverse patients means sponsors must start engaging patients early in the trial planning efforts. Novotech Global Head, Drug Development Consulting Scott D. Schliebner, MPH, lamented that often protocols are developed “in a conference room in New Jersey” and are not pressure-tested against patient availability and site operations. As an example, Schliebner mentioned a biotech client with an eight-person team that needed careful planning of its trial that studied an investigational drug in both white American populations and native Asian populations, one slow and one quick enrollment, to balance time and money.
CEO of the Community Liver Alliance Suzanna Masartis — as many patient advocates do — implored pharma to connect with advocacy groups to reach patients and better understand how their condition affects their everyday lives and how they perceive trial participation. Incredibly, Masartis said that not one sponsor company has reached out to her group to provide patient input for protocol design. Rather, and as is often the case, the sponsor presented her with a finished protocol for patients to review. It’s not only a too-little-too-late approach, it also could be bad for business.
Bentouati said sponsors should decide which patients to reach as early as devising the clinical development plan. Not doing so might seem to speed up the trial process, but it could actually cost companies as they run the risk of regulators enforcing post-marketing requirements. Another wait-and-see approach Bentouati roundly rejects is collecting real-world evidence as a means to patch up a poorly planned trial. As she says, “RWE doesn’t give us a pass not to do our best in clinical trials.”
All of this is advice is well and good, if business leaders prioritize it. Early in the conversation, HealthTequity Cofounder and Chief Technology Officer Vinay Pai, Ph.D., MBA, quietly but clearly pointed to an economic reality: If sponsors strive to enroll more diverse patients — by opening sites in rural areas, by expanding to other countries, or by other concerted diversity efforts — their profit margins will likely suffer. The more challenging the patient access, the more costly the sponsors’ endeavors will be, he said. Schliebner later built upon that stark remark, reminding us all that sponsors might idealize diversity but prioritize time-to-market.
The group offered some tangible ways to keep diverse enrollment alive and well, but they didn’t fully flesh out the question of whether pharma decision makers will do the “right thing” and make the “good science” call in the end. Without formal FDA backing, panels like these will likely persist on conference agendas, and the staunchest of “good science” supporters must continue to speak — and act — until the fidgeting stops.