How sponsors build a diverse enrollment pipeline without slowing the study

Diverse enrollment and fast enrollment tend to get talked about as if they were pulling against each other. They usually aren't.

When sponsors design their enrollment strategy to reach a wider range of communities from the start, the study that follows tends to run more smoothly, not less. Community-based sites reach the participants; a pivotal study needs to be representative, and they usually activate faster than large academic centers. Culturally competent pre-screening improves the quality of every referral that reaches a site. Decentralized elements open geographic markets that no single site could cover on its own.

Here's a look at what the FDA Diversity Action Plan actually asks for, then a walk through the three velocity metrics where a diverse pipeline pays off.

What the FDA Diversity Action Plan actually asks for

The Diversity Action Plan (DAP) requirement comes from the 2022 Food and Drug Omnibus Reform Act (FDORA). It applies to Phase 3 or other pivotal drug studies, and to most device studies that go through an investigational device exemption (IDE), 510(k), De Novo request, or premarket approval (PMA). Sponsors submit the plan at the same time they submit the study protocol to FDA.

The plan itself has three parts. Enrollment goals broken out by race, ethnicity, sex, and age group. The reasoning behind those goals, based mainly on U.S. prevalence or incidence of the disease in the population, is that the drug or device is meant to help. And the steps the sponsor will take to meet those goals across enrollment, retention, and monitoring.

FDA released its most recent draft guidance in June 2024. The comment period closed that September, and the statute set a mid-2025 deadline for finalization. That deadline came and went without a final version. The guidance was briefly pulled from FDA's website in early 2025 and restored shortly after by court order. As of mid-2026 it's still in draft, enforcement has been uneven, and the underlying FDORA statute is unchanged. FDA has already accepted hundreds of voluntary DAPs across the past two fiscal years, and most regulatory counsel are telling sponsors to keep preparing them.

One detail worth knowing: the statute asks sponsors to submit a plan and report on progress. It doesn't ask sponsors to hit every goal exactly. If enrollment tracks below plan, the sponsor explains why in periodic reports and describes what's being done about it. That gives real room to set ambitious goals without worrying a shortfall will derail an approval. For a broader take on where sponsor recruitment strategy needs to shift, see The Ongoing Challenge of Clinical Trial Recruitment: What Sponsors Must Change.

Why diverse outreach usually speeds things up, not down

The worry behind 'diversity slows the study' is that expanding into new communities and new geographies takes longer to convert into randomized participants than working through the academic networks sponsors already know. The available data points the other way.

A 2025 analysis in Frontiers in Medicine looked at enrollment performance across site models in a large Alzheimer's disease trial. Decentralized, community-integrated sites screened and randomized participants at a higher monthly rate than traditional academic-only sites. The authors were affiliated with the vendor operating the community model, so treat the numbers as directional rather than as independent proof. Even so, the pattern lines up with what Tufts Center for the Study of Drug Development has been documenting for years. Community and physician-practice sites tend to activate faster and enroll faster than large academic medical centers.

The opposite pattern is what happens when sponsors don't diversify. Enrollment concentrated in a familiar handful of academic sites produces strong early numbers that then plateau, because the easily reached participants get enrolled and the study stalls once the remaining eligible population is spread across geographies the sponsor didn't plan for. That late-stage plateau is the enrollment crisis sponsors worry about, and its cause is narrow outreach, not diverse outreach. More on how community networks expand participant pools in How Community Physicians Can Expand Clinical Trial Participant Pools.

Time-to-first-patient and the enrollment curve

The first velocity metric worth looking at is time-to-first-patient (TTFP), along with the shape of the enrollment curve that follows. National Cancer Institute site activation targets sit at 90 days. Actual median site activation times across academic and community centers run roughly 140 to over 300 days depending on the cohort and therapeutic area. Tufts CSDD data shows physician-practice sites activate faster than academic and government sites, and specialized community networks activate faster still.

This is where diverse enrollment and speed line up cleanly. Community and physician-practice sites tend to sit geographically closer to the underrepresented populations sponsors are trying to reach, and their activation processes are usually leaner than those at tertiary academic medical centers. Diversifying a site list with vetted community partners doesn't just broaden the pipeline. It often shortens the path to the first randomized participant.

Community engagement built during feasibility, not after protocol finalization, also smooths the enrollment ramp. When the protocol is already calibrated to the population it needs to reach, per-site enrollment tends to be steadier once the study opens. A deeper look at why time-to-first-patient matters is available in The Hidden Cost of Slow Recruitment in Clinical Trials: Why Time-to-First-Patient Matters.

Screen failure rates and qualified-referral yield

Screen failure rates are the second velocity metric, and one of the most painful. Across neurodegenerative and oncology trials, screen failure rates commonly land between 50 and 90 percent. The main cause is candidates who don't meet inclusion or exclusion criteria after in-clinic assessment, and every failed screen costs site staff time and sponsor budget.

Diverse enrollment strategies help here in two connected ways. First, pre-screening that's culturally competent, multilingual, and delivered at the right reading level lifts the yield of qualified referrals reaching the site. Reading level, language access, and cultural framing all shape whether a candidate really understands what the study is asking of them and can accurately self-report the criteria that matter. Second, screen failures among underrepresented subgroups hit demographic representation harder than screen failures in larger pools. Losing candidates from a small subgroup is a much bigger dent in representation than losing the same number from a larger one.

Digital pre-qualification tools that filter candidates against protocol criteria earlier in the funnel cut the volume of unqualified referrals reaching the site, and they can be built with language and reading level baked in from day one. For a closer look at where screen failures cost sponsors most, see The Hidden Cost of Screen Failures in Clinical Trials.

Site activation and geographic reach

The third velocity metric is site activation and the geographic footprint that activation produces. Expanding beyond the traditional academic center network enlarges the addressable population and brings the site network closer to Census-representative demographics. Community sites, federally qualified health centers, and safety-net clinics reach populations that are hard to enroll through academic referral pathways alone.

The trade-off is that individual community sites can be research-naïve, and they may activate more slowly than experienced academic centers. Network partnerships, hub-and-spoke designs, and site management organizations mitigate that by pre-qualifying community sites and providing infrastructure support. Home visits, local providers, local laboratory services, and mobile units also help extend study reach without asking every participant to travel to a central site.

The result is a geographically distributed site network that can enroll from rural, urban underserved, and demographically diverse populations no single academic center could reach on its own. When an enrollment plan is underperforming, geographic and site-network design is often the deeper cause, and How Sponsors Find the Real Cause of Slow Clinical Trial Enrollment walks through that diagnostic.

Building the diversity pipeline early in trial design

The common thread across all three velocity metrics is timing. Diversity added onto a study after site activation is what creates the delays sponsors are trying to avoid. Diversity built into feasibility, protocol design, site selection, and pre-screening infrastructure is what protects the timeline and produces enrollment that reflects the disease population.

In practice, that looks like setting enrollment goals grounded in the epidemiology of the disease during feasibility, testing eligibility criteria against a realistic representative pool before the protocol is locked, choosing a site network that already reaches the target demographics, and equipping pre-screening with the language, reading level, and cultural competence to convert qualified candidates.

DecenTrialz supports this work as an AI-assisted participant matching and pre-screening platform for U.S.-based clinical studies. AI-assisted matching reaches candidates from broader geographic and demographic pools than traditional site referral networks capture on their own. Registered nurse-led pre-screening applies culturally competent, appropriately leveled conversations before candidates reach the site, which lifts qualified-referral yield and reduces the demographic-skewing effect of downstream screen failures. Structured referral workflows keep the research site in control of the study walk-through, final eligibility, informed consent, and enrollment.

Sponsors looking at platform partners can review Partnering for Success: What Sponsors Should Look for in a Recruitment Platform for a fuller selection framework, and can see how DecenTrialz builds diverse pipelines at decentrialz.com.

Frequently asked questions about diverse enrollment pipelines

Do sponsors need a Diversity Action Plan for a pivotal study in 2026?

The FDORA statute requiring Diversity Action Plans is still on the books. FDA's guidance on how to prepare them is in draft form as of mid-2026, so the formal clock hasn't started. FDA has continued to accept voluntary DAPs, hundreds of them, and most regulatory counsel are recommending that sponsors preparing pivotal drug or device submissions keep preparing DAPs as if finalization were imminent.

Does broadening outreach slow enrollment?

The evidence points the other way. Community and physician-practice sites tend to activate and enroll faster than academic sites in most therapeutic areas, and geographically distributed networks reach eligible participants that narrow outreach never finds. The enrollment plateau sponsors sometimes associate with diverse outreach is more commonly caused by narrow outreach that burns through easily reached participants early.

What is the biggest mistake sponsors make with diverse enrollment?

Adding diversity late is the most common and most expensive one. Bringing in diverse site partners, community engagement, or multilingual pre-screening after site activation limits how much they can shift the enrollment curve. Building diversity into feasibility and protocol design produces steadier enrollment and a study that runs more smoothly all the way through.

How should sponsors set enrollment goals by demographic subgroup?

The starting point is U.S. prevalence and incidence of the disease in the population the drug or device is meant to help. Most sponsors pair that epidemiology data with population access data such as site catchment and community network reach, then set goals that are ambitious but achievable. Goals should be documented with reasoning, and progress reported in periodic filings.

Partner with DecenTrialz to build a diverse and timely enrollment pipeline

Diverse enrollment and timely enrollment are the same goal, seen from two angles. Sponsors who design for diversity at feasibility protect their timelines. Sponsors who add diversity late lose them. DecenTrialz combines AI-assisted participant matching with registered nurse-led pre-screening and structured referral workflows, built to broaden reach and lift qualified-referral yield for U.S.-based pivotal studies. Visit decentrialz.com to see how a diverse enrollment pipeline can protect clinical trial timelines from feasibility through last-patient-in.