The Hispanic section is where most DAPs lose credibility at FDA review.
We build that section.
FDORA mandates Diversity Action Plans for Phase 3 and other pivotal trials. Hispanic Americans are 18 percent of the US population and the group most commonly absent from Phase 3 enrollment. Hispanic Healthbridge builds the Hispanic component of your DAP, the enrollment goals, the rationale, and the operational recruitment program behind them, written to FDA guidance standards.
What FDORA actually requires, and what FDA expects to see
The Food and Drug Omnibus Reform Act, enacted in 2022, requires sponsors to submit a diversity action plan for Phase 3 clinical trials and other pivotal studies. Each plan must include three things: enrollment goals for patient populations representative of intended use, the rationale for those goals, and an operational plan to meet them. The FDA issued draft guidance in June 2024 and has not yet finalized it.
The plan is submitted with the IND or as a protocol amendment. FDA can request modifications. Sponsors who underperform against their stated goals will face questions at future submissions. This is not a one-time checkbox; it is an ongoing accountability mechanism built into the regulatory relationship.
Hundreds of sponsors are submitting Diversity Action Plans voluntarily under the existing framework. The 180-day compliance clock starts when final guidance is published, but Phase 3 infrastructure has 12 to 18 month lead times. Sponsors who wait for finalization will not have time to build the operational measures the guidance requires.
The strategic point most sponsors miss is that the DAP requirement is statutory, not regulatory. The FDA cannot eliminate it by withdrawing or modifying guidance. The compliance clock has not started, but voluntary submissions have. Sponsors who skip the practice round will be visibly behind on day one.
What FDA requires in a diversity action plan
- Enrollment goals for patient populations representative of intended use
- Evidence-based rationale for each goal
- An operational plan to meet those goals
- Submitted with IND or as a protocol amendment
- Subject to FDA review, comment, and modification request
- Progress against goals tracked across the trial lifecycle
This is not a compliance document exercise. It is a recruitment problem.
FDA reviewers know what a credible Hispanic enrollment strategy looks like, and they know what a box-checking exercise looks like. The difference is not the length of the plan. It is whether the plan reflects an understanding of why Hispanic patients are commonly absent from Phase 3 enrollment, what specific barriers your trial will face, and what operational infrastructure will actually produce enrollment.
A diversity action plan that cannot answer those questions will not satisfy FDA. More importantly, it will not produce the enrollment numbers that FDA will be tracking against your submission.
Why translation is not an enrollment strategy
Hispanic patients exist. They have the diseases your trial is studying. They live within driving distance of your trial sites. What they do not have is a reason to trust the process, and generic outreach does not address that.
A Mexican-American patient in Phoenix and a Puerto Rican patient in the Bronx share an ethnic category in CRF demographics. They share neither pharmacogenetic profile, dietary patterns, comorbidity prevalence, nor healthcare access pathways. Treating them as interchangeable produces label data that misrepresents both. This is precision medicine. Subgroup analysis at Phase 3 is the regulatory expression of it.
Trust architecture
Hispanic patients rely on family networks, community health workers, and trusted clinicians for health decisions, not mass communications. Outreach that does not originate from a trusted source does not move people to action.
Familismo
Health decisions in Hispanic households are often collective. A patient cannot consent to trial participation without family alignment. Recruitment programs that speak only to the individual patient miss the actual decision-making structure.
Language is not just words
Materials translated from English carry the cultural assumptions embedded in the original. Idiomatic Spanish written for the community, not translated for compliance, is meaningfully different in how patients receive and act on it.
Channel matters
Hispanic patients engage through the channels where their community already lives: WhatsApp, Spanish-language media, community organizations. Email and patient portal outreach reach a fraction of the population you are trying to recruit.
Structural barriers
Insurance status, transportation, Spanish-speaking coordinator availability, and work schedule constraints create overlapping barriers that vary by site geography and disease area. A single outreach approach does not clear all of them.
Site staff readiness
Trial coordinators without experience enrolling Hispanic patients will struggle regardless of how good the outreach is. Site readiness, including culturally responsive enrollment conversations and Spanish-language consent support, is part of the recruitment infrastructure.
How we build the Hispanic component of your DAP
Two levels of engagement: strategic advisory on the Hispanic component of the DAP, and operational design of the recruitment program behind it. The five steps below are the structure.
Community & site landscape analysis
Map the Hispanic patient population near your trial sites, by subgroup, language preference, disease prevalence, and healthcare access patterns. Puerto Rican, Mexican-American, and Central American communities have distinct trust architectures. Effective enrollment strategy starts here, not at the brochure.
Barrier identification by disease area
Structural barriers to trial participation vary by therapeutic area. We map the specific barriers your trial will face: insurance access, language-concordant provider scarcity, and community misinformation.
Enrollment goal development with FDA rationale
We build Hispanic enrollment targets from disease prevalence data, site catchment population data, and realistic community engagement capacity. The rationale is written to FDA guidance standards.
Recruitment program design
Build the actual outreach infrastructure: bilingual materials in idiomatic Spanish, mobile-first delivery through channels Hispanic patients already use, community health worker integration, site staff training on culturally responsive enrollment conversations, and community partner activation.
Submission documentation
Produce the Hispanic enrollment section of the diversity action plan with FDA-required components: enrollment goals, rationale, and operational plan. Formatted for IND submission or protocol amendment, referencing published methodology and evidence-based design principles where applicable.
Why the argument is built indication by indication
Generic Hispanic enrollment frameworks are weaker than indication-specific ones. The arguments below are the spine of our rheumatology and rare disease practice.
Lupus (SLE)
Hispanic and Black women are disproportionately affected by SLE, with greater morbidity and mortality than non-Hispanic white women. SLE is a leading cause of death among young Hispanic and Black women. Any Phase 3 lupus trial that does not enroll a representative Hispanic cohort produces label data that does not generalize to the population that bears the disease burden. Label generalizability requires representative enrollment.
Rheumatoid arthritis (RA)
Hispanic RA patients present at younger ages, with higher disease activity at diagnosis, and have lower rates of biologic treatment access. The HOPE-CAPE RA evidence base, published in RMD Open and presented at ACR Convergence 2022 and 2023, is the strongest single dataset on Hispanic RA patient education. This is the home indication.
Psoriatic arthritis and psoriasis
PsA prevalence varies substantially across Hispanic subgroups. Skin manifestation visibility differs by skin tone in ways that affect diagnosis timing. Sponsors developing PsA biologics often submit DAPs that treat Hispanic as a single homogeneous category. Subgroup-specific design is correctable at engagement.
Hereditary ATTR amyloidosis
Hereditary ATTR has documented Latin American clusters, particularly in Brazil and Portugal-descended populations and in specific Mexican states. Phase 3 sponsors targeting hereditary ATTR cannot avoid the geographic concentration of their patient population. Cultural and linguistic framework matters at the recruitment step.
Generalized myasthenia gravis (gMG)
gMG has a documented predominance in Black and Hispanic women, particularly at younger ages of onset. Sponsors developing gMG therapeutics are running directly into this enrollment design problem.
Your Indication
We apply this same principle to your indication. Accurate Hispanic representation is essential for generating clinical data that truly reflects the population your therapy will serve. From protocol design through recruitment and engagement, we help you enroll the right patients.
The multinational study trap
Many Phase 3 programs are designed as global studies with US enrollment as one component of a larger multinational dataset. The draft DAP guidance addresses this directly: a sponsor cannot satisfy US Hispanic enrollment goals by enrolling Latin American patients in OUS sites. The intended use population is US Hispanic, which is genetically, culturally, and clinically different from a population enrolled at, for example, a Mexico City study site.
The trap is correctable only at protocol design, not after enrollment opens. Catching this in protocol review is one of the highest-leverage advisory interventions in the practice.
Specific outputs for pharma medical affairs and clinical operations
Every engagement is scoped to what your trial and your team actually need. These are the typical deliverables from a Hispanic Healthbridge diversity action plan engagement.
Written FDA diversity action plan: Hispanic section
The enrollment goals, rationale, and operational plan for Hispanic participants, formatted for IND submission or protocol amendment and written to FDA guidance standards.
Enrollment goal rationale document
Evidence-based justification for your Hispanic enrollment targets, grounded in disease prevalence data, site catchment population data, and community engagement capacity.
Bilingual recruitment materials
Patient-facing materials written in idiomatic Spanish, not translated from English, and designed for mobile-first delivery. IRB-ready where applicable.
Site engagement playbook
Guidance for trial coordinators on culturally responsive enrollment conversations, Spanish-language consent support, and community referral pathways specific to each site’s patient population.
Community partnership activation plan
Identification and engagement strategy for community organizations, promotores de salud, and trusted Hispanic clinicians who can extend recruitment reach into the communities your sites serve.
Mobile-first outreach program design
Channel strategy and content plan for reaching Hispanic patients through WhatsApp, Spanish-language media, and community-trusted digital channels, designed around where patients already receive health information.
Enrollment tracking framework
Metrics structure and progress reporting template for tracking Hispanic enrollment against your DAP goals throughout the trial, including early-warning indicators and course-correction triggers.
Strategic advisory
For teams earlier in the process: advisory support on protocol design decisions that affect Hispanic enrollment, site selection informed by Hispanic patient population data, and DAP strategy before the plan is written.
This is not a DEI consultation. It is an enrollment strategy backed by clinical research.
- Every recommendation is grounded in Dr. Hernandez’s published, peer-reviewed research on Hispanic patient engagement, not general health equity principles.
- The methodology has IRB approval, conference presentation, and retention data behind it. That matters to FDA reviewers and to your medical affairs leadership.
- Engagements are scoped precisely to your trial phase, therapeutic area, and site geography, not a generic Hispanic outreach package.
- The methodology was proven in rheumatology patient populations and transfers directly to rare disease and other specialty indications. The implementation is always disease-specific, indication-specific, and site-specific.
Talk to us about your diversity action plan
Whether you are at the IND stage, preparing a protocol amendment, or building the Hispanic component from scratch, we scope the engagement in a first call.