FDA Finalizes Guidance on Diversity Action Plans for Clinical Studies
Published February 2026 — Analysis of the finalized guidance requiring diversity action plans for pivotal clinical trials, including implementation requirements, demographic enrollment targets, and site-level compliance obligations.
Legislative Context and Regulatory History
The FDA’s finalized guidance on Diversity Action Plans for Clinical Studies represents the culmination of a multi-year effort to address persistent demographic disparities in clinical trial enrollment. For decades, clinical trials have disproportionately enrolled White participants, with Black, Hispanic, Asian, and other racial and ethnic groups consistently underrepresented relative to their share of the disease population. This imbalance has direct consequences for the generalizability of safety and efficacy data and, ultimately, for equitable access to therapeutic innovations.
The legislative foundation for this guidance was established by the Food and Drug Omnibus Reform Act (FDORA), signed into law in December 2022 as part of the Consolidated Appropriations Act of 2023. Section 3601 of FDORA granted the FDA explicit authority to require sponsors to submit diversity action plans as part of clinical development programs for drugs, biologics, and certain medical devices. The statute directed the FDA to issue guidance within two years detailing the specific requirements, submission timelines, and enforcement expectations.
The FDA released a draft guidance document in June 2024, followed by a 90-day public comment period that generated over 1,200 submissions from sponsors, academic research organizations, patient advocacy groups, site networks, and individual investigators. The finalized guidance, released in February 2026, incorporates significant revisions based on this feedback — particularly around the flexibility of demographic enrollment targets and the practical implementation burden on clinical research sites.
Key Requirements
The finalized guidance establishes specific requirements for which trials need diversity action plans, when plans must be submitted, and what elements each plan must contain.
All Phase III clinical trials and pivotal efficacy studies must include a diversity action plan, regardless of therapeutic area. This applies to new drug applications (NDAs), biologics license applications (BLAs), and premarket approval applications (PMAs) for Class III medical devices.
Late-stage Phase II studies intended to serve as pivotal evidence for regulatory submission, or Phase II studies in disease areas with documented health disparities (as defined by the HHS Office of Minority Health), must also include a diversity action plan.
Diversity action plans must be submitted to the FDA no later than 120 days prior to the anticipated first-patient-in date. Plans submitted after this deadline may result in a clinical hold or request for additional information that delays study initiation.
Each plan must include: (1) demographic enrollment targets with rationale, (2) site selection strategy addressing diversity, (3) community engagement plan, (4) retention strategy for underrepresented populations, (5) data collection and reporting methodology, and (6) contingency plan for enrollment shortfalls.
Demographic Enrollment Targets
One of the most debated aspects of the draft guidance was the question of how sponsors should establish demographic enrollment targets. The finalized guidance adopts a “flexible targets with rationale” approach that reflects the practical realities of clinical trial enrollment while maintaining accountability for meaningful diversity outcomes.
Benchmarking Methodology
Sponsors are required to establish demographic enrollment targets based on the best available epidemiological data for the condition under study. Acceptable data sources include the CDC’s National Health Interview Survey, CMS claims databases, disease-specific registries, published prevalence studies, and real-world data from electronic health record aggregates. The guidance explicitly states that U.S. Census data alone is insufficient as a benchmarking basis — targets must reflect disease-specific demographics, not general population demographics.
For rare diseases where epidemiological data is limited, the guidance permits sponsors to reference published case series, natural history studies, and expert clinical opinion as supplementary data sources, provided the rationale is documented in the diversity action plan.
Flexible vs. Mandatory Targets
The finalized guidance adopts a tiered approach to target flexibility. For demographic groups that are disproportionately affected by the condition under study, enrollment targets are characterized as “enrollment goals with accountability” — meaning sponsors must demonstrate good-faith efforts to meet targets and provide documented justification for any significant shortfalls. For other demographic groups, targets are characterized as “aspirational benchmarks” that guide site selection and recruitment strategy without creating a compliance obligation.
Importantly, the guidance clarifies that failure to meet enrollment targets does not automatically result in a refuse-to-file decision or clinical hold. Instead, the FDA will evaluate the sponsor’s documented efforts, the adequacy of the contingency measures deployed, and whether the final enrollment demographics provide sufficient data to assess safety and efficacy across relevant subgroups.
Reporting and Accountability
Sponsors must submit interim diversity enrollment reports at the midpoint of enrollment and at enrollment completion. These reports must include actual enrollment demographics compared to targets, site-level enrollment demographics (aggregated to prevent patient identification), community engagement activities completed, and any modifications to the diversity action plan made during the study. The FDA may request additional reporting for studies where interim data indicates significant deviation from enrolled diversity targets.
Site-Level Implications
While the diversity action plan is a sponsor-level obligation, its implementation has significant downstream effects on clinical research sites. Sites should prepare for the following operational requirements.
Sites are expected to demonstrate active community engagement strategies, including partnerships with community health centers, faith-based organizations, and patient advocacy groups that serve underrepresented populations. The guidance emphasizes that community engagement must be ongoing and bidirectional — not limited to one-time outreach events at the start of a study. Sites should document all engagement activities and maintain records of community partnerships.
The guidance reinforces the expectation that informed consent materials should be available in languages spoken by the target patient population within each site’s catchment area. Sites must have qualified personnel or certified medical interpreters available for consent discussions in non-English languages. Translated consent documents must be IRB-approved and maintained as part of the regulatory binder. Sites in regions with significant non-English-speaking populations should proactively prepare translated materials.
Sponsors are directed to incorporate diversity potential into their site selection criteria. This means sites located in diverse communities, sites affiliated with safety-net hospitals or federally qualified health centers, and sites with demonstrated track records of enrolling diverse populations will receive heightened consideration during feasibility. Sites should be prepared to provide demographic data about their patient populations and prior trial enrollment demographics during the feasibility assessment process.
Sites will be required to collect and report granular demographic data for all screened and enrolled participants, including race, ethnicity, age, sex, and gender identity. This data must be captured using standardized categories aligned with OMB Directive 15 (revised). Sites should update their screening and enrollment workflows to ensure this data is captured consistently and transmitted to sponsors in the required format.
The guidance recommends that site staff involved in patient-facing activities complete cultural competency and health equity training. While not a mandatory requirement for individual sites, sponsors may include this as a qualification criterion for site selection. Sites that can demonstrate existing cultural competency programs will have a competitive advantage in attracting studies that require robust diversity action plans.
Diversity enrollment is only meaningful if participants are retained through study completion. Sites are expected to implement retention strategies that address barriers disproportionately affecting underrepresented populations, including transportation assistance, flexible visit scheduling, childcare support, and culturally appropriate follow-up communication. The guidance encourages sponsors to provide adequate budgets for these site-level retention activities.
Implementation Timeline
The finalized guidance establishes a phased implementation timeline designed to give sponsors and sites adequate time to develop the infrastructure, processes, and partnerships necessary for compliance.
Immediate Effect (February 2026)
The guidance is effective upon publication for all new IND submissions and new protocol submissions under existing INDs. Sponsors submitting new Phase III or applicable Phase II protocols after February 2026 must include a diversity action plan as part of the protocol submission package.
Six-Month Transition (August 2026)
Studies with protocols already submitted but not yet enrolling have a six-month window to file a supplementary diversity action plan. The FDA will provide a streamlined submission pathway for these transitional cases. During this period, the agency will focus on education and technical assistance rather than enforcement actions.
Full Enforcement (February 2027)
Beginning one year after publication, full enforcement expectations apply. The FDA will review diversity action plans as part of its standard protocol review process. Inadequate plans may result in requests for additional information, clinical holds, or — in cases of material noncompliance — refuse-to-file decisions. The agency has indicated that enforcement will be proportionate, focusing first on the adequacy of the plan itself rather than on whether specific enrollment targets were achieved.
Clinitiative Network Readiness
The Clinitiative network has been proactively building diversity enrollment capabilities in anticipation of this guidance. Our sites are well-positioned to support sponsors in meeting their diversity action plan requirements.
Across all active studies, 42% of participants enrolled at Clinitiative network sites identify as members of racial or ethnic minority groups — significantly above the industry average of 25% reported by the FDA's Drug Trials Snapshots program.
The network maintains active partnerships with 68 community health organizations, faith-based groups, and patient advocacy organizations specifically focused on connecting underrepresented populations with clinical research opportunities.
Clinitiative network sites collectively offer informed consent processes and study coordination in 14 languages, with certified medical interpreter services available on-demand for additional languages through our centralized language access program.
All patient-facing staff across the Clinitiative network have completed cultural competency and health equity training as part of the ClinFirst governance framework. This training is refreshed annually and includes modules on implicit bias, culturally sensitive communication, and health literacy.
What This Means for Sponsors
The finalized guidance fundamentally changes the planning timeline for clinical development programs. Diversity action plans cannot be developed as an afterthought — they require early integration into protocol design, site selection strategy, and budget planning. Sponsors should be prepared to invest in the data infrastructure needed to establish evidence-based demographic enrollment targets, including access to disease-specific epidemiological datasets and real-world data sources.
Site selection will increasingly prioritize diversity capability alongside traditional feasibility metrics. Sponsors who rely exclusively on high-volume academic medical centers — many of which serve relatively homogeneous patient populations — may need to expand their site portfolios to include community-based research sites, safety-net hospital affiliates, and sites in geographic regions with greater demographic diversity. The budget implications are not trivial: community engagement activities, multilingual consent processes, and enhanced retention strategies all require dedicated funding.
However, the guidance should also be viewed as an opportunity. Trials with diverse enrollment generate data that is more representative, more defensible in regulatory review, and more relevant to the populations who will ultimately use the approved therapies. The long-term return on diversity investment — measured in regulatory confidence, label breadth, and market access — is substantial.
Need Help Preparing Your Diversity Action Plan?
Contact our regulatory affairs team to learn how the Clinitiative network can support your diversity enrollment strategy and compliance requirements.