Starting Q4 2025, every Phase 3 trial sponsor must submit a Diversity Action Plan to the FDA. Sites that can't demonstrate diverse enrollment capability will lose sponsor partnerships. Here's what you need to know — and what to do now.
Updated March 2026 · Based on FDA draft guidance, FDORA Sections 505(z) & 520(g), and HHS OIG 2024 report
The FDA Omnibus Reform Act (FDORA), enacted December 29, 2022, creates mandatory Diversity Action Plan (DAP) requirements for clinical trial sponsors. This is not guidance — it is law under Sections 505(z) and 520(g) of the Federal Food, Drug, and Cosmetic Act.
Which trials require a DAP: Phase 3 pivotal drug trials, medical device pivotal studies (with IDE), and biological product trials. Early-phase exploratory studies may qualify for a waiver.
What Diversity Action Plans must include:
Site Implication: Sponsors will select research sites based on demonstrated ability to hit diversity enrollment targets. Sites without diversity data, community partnerships, and documented strategies will be deprioritized for Phase 3 trials.
| Date | Event | Impact |
|---|---|---|
| Dec 2022 | FDORA enacted into law | DAP requirement becomes federal law |
| Jun 2024 | FDA releases draft guidance on DAPs | Detailed implementation framework published |
| Sep 2024 | Industry comment period closes | FDA reviewing feedback from sponsors and CROs |
| Jun 2025 | Final guidance due (statutory deadline) | FDA legally required to finalize DAP guidance |
| ~Dec 2025 | DAP requirements go live | All new Phase 3 trials must submit DAPs (180 days after final guidance) |
| 2026–2027 | DAPs are the new standard | Sites competing for Phase 3 trials judged on diversity performance |
Current status (March 2026): FDA temporarily removed its draft guidance in January 2025 following administration EOs on DEI programs, then restored it with notation. The underlying FDORA statute was passed by Congress in 2022 and cannot be unilaterally removed — the legal requirement remains in effect. Sites that prepare now gain a competitive window while others wait to see what happens.
For research sites, FDORA doesn't create a direct obligation — it creates an indirect one that's just as powerful: your sponsors are required to hit diversity targets, and they will route trials to sites that help them do it.
How this plays out in site selection:
The hard truth: 2 out of 3 NIH-funded trials with diversity plans still miss their enrollment targets. The gap isn't intent — it's infrastructure. Sponsors know this and will reward sites that have built the right systems before the DAP deadline.
For Seattle research sites specifically: The Seattle metro area has a large Latino (10%+), Asian, Black, and Native American population. Sites here have access to diverse patient pools that many other markets don't — but only if you have the outreach infrastructure and community trust to reach them.
Pull race, ethnicity, age, and sex breakdown from your last 3–5 trials. Compare against disease population prevalence. This baseline is what sponsors will ask about — and what you'll need to write your site-level contribution to a DAP.
Most enrollment failures aren't refusals — they're never-asked problems. Identify 3–5 community organizations, faith communities, or cultural health advocates in your area and begin outreach relationship building before your next Phase 3 trial launches.
Language barriers are one of the top cited reasons for diversity enrollment failure. Document your team's language capabilities and identify gaps. Consider translation services and materials for your top 2–3 non-English languages in your patient population.
Sponsors writing DAPs need to cite specific site strategies. Having a written, structured diversity outreach plan — even a one-pager — positions your site as a credible DAP contributor and differentiated partner versus sites that operate reactively.
FDORA timelines are now. If you need to build outreach infrastructure (digital advertising, community partnerships, patient navigation), starting now gives you time to test and iterate before Q4 2025 deadlines hit. Sites scrambling at the last minute will be at a disadvantage.
TrialEnrollPros is a clinical trial diversity enrollment and retention platform built specifically for research sites navigating the FDORA mandate. We provide the infrastructure, community connections, and data reporting that sponsors will require from their Phase 3 site partners.
The competitive frame: Sites using TrialEnrollPros can demonstrate to Phase 3 sponsors that they have the infrastructure to hit diversity targets — making them preferred partners in the DAP process. Early movers have significant advantage before the market becomes crowded with sites trying to solve this in Q3 2025.
Get a 30-minute consultation with our clinical recruitment team. We'll assess your current enrollment data, identify gaps, and show you exactly how TrialEnrollPros positions your site ahead of FDORA deadlines.