FDORA mandates diversity action plans for Phase 3 and other pivotal trials. Hispanic Americans are 18 percent of the U.S. population and among the most underrepresented groups in clinical research. Hispanic Healthbridge helps pharma medical affairs teams build the enrollment strategy behind the plan, not just the plan itself.
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 underrepresented populations, the rationale for those goals, and an operational plan to meet them. FDA has issued guidance specifying what adequate plans look like.
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.
The guidance is explicit: FDA is looking for evidence-based enrollment goals, a credible plan to reach underrepresented populations, and documentation that the sponsor understands why generic outreach has historically failed. A translated brochure and a bilingual 1-800 number will not satisfy a rigorous FDA review.
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 underrepresented, 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.
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.
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.
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.
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.
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.
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.
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.
Dr. Hernandez works with pharma medical affairs and clinical operations teams at two levels: strategic advisory on the diversity action plan itself, and operational design of the recruitment program behind it. The five-step framework below is the structure that underlies every engagement.
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.
Hispanic patients face structural barriers to trial participation that vary by therapeutic area. We map the specific barriers your trial will face, including insurance access, language-concordant provider scarcity, and community misinformation, before designing the program to address them.
FDA requires sponsors to justify their diversity enrollment goals with evidence. We build your Hispanic enrollment targets using disease prevalence data, site catchment population data, and realistic community engagement capacity, then write the rationale in the form FDA expects to receive it.
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.
Produce the written diversity action plan section 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.
Daniel Hernandez, MD, the advisor behind the plan
Dr. Hernandez built and published the model. He was principal investigator on HOPE-CAPE RA, the $1 million BMS Foundation grant that became the national standard for culturally adapted Hispanic patient education and the first-ever RA grant in BMS Foundation history. That program produced a two-year IRB-approved methodology with 100% patient advisory board retention, published in RMD Open and presented at ACR Convergence.
He also built the WhatsApp-based patient support platform recognized by Fierce 50 as a breakthrough in non-English healthcare outreach, a model that ran weekly for two years and kept every enrolled participant. He co-led the first formal study of Hispanic RA patient support needs, conducted with Hospital for Special Surgery and presented at ACR Convergence.
When FDA reviewers look at a diversity action plan that references peer-reviewed methodology, IRB-approved program design, and published retention outcomes, that is a credibility signal that generic health equity consulting cannot provide. That evidence base is what Dr. Hernandez brings to your submission.
Talk to us about your trialEvery 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.
The enrollment goals, rationale, and operational plan for Hispanic participants, formatted for IND submission or protocol amendment and written to FDA guidance standards.
Evidence-based justification for your Hispanic enrollment targets, grounded in disease prevalence data, site catchment population data, and community engagement capacity.
Patient-facing materials written in idiomatic Spanish, not translated from English, and designed for mobile-first delivery. IRB-ready where applicable.
Guidance for trial coordinators on culturally responsive enrollment conversations, Spanish-language consent support, and community referral pathways specific to each site’s patient population.
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.
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.
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.
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.
Whether you are at the IND stage, preparing a protocol amendment, or designing your enrollment program from the ground up, Dr. Hernandez can help you build a Hispanic enrollment strategy that satisfies FDA and actually performs.