FDA Diversity Action Plans and Cardiovascular Trial Site Selection — A Sponsor's Strategic Guide

This guide explains what DAPs are, what FDA expects, how the requirements affect cardiovascular site selection, and how sponsors should think about enrollment-diverse site strategy in 2026.

What's in scope

FDA's Diversity Action Plan requirements apply to:

• Phase 3 trials of drugs (and biologics)
• Pivotal device studies that require pre-market submission
• Other clinical investigations FDA designates

For most cardiovascular sponsors, this means any Phase 3 trial supporting NDA, BLA, or PMA submissions. Phase 1 and Phase 2 trials are not formally in scope, but FDA explicitly encourages sponsors to consider diversity from earlier phases — and reviewers often look for it.

The guidance is not a one-size-fits-all enrollment quota. It's a planning, transparency, and execution requirement. Sponsors submit a DAP describing:

• The demographic enrollment goals for the trial (by age, sex, race, ethnicity)
• How the goals were derived from the disease prevalence and patient population
• How the sponsor will achieve the goals (site selection, recruitment, retention)
• How outcomes will be reported

How DAPs change site selection for cardiovascular trials

In practice, DAPs have shifted cardiovascular trial site selection in four observable ways since the Final Guidance.

1. Site demographic profile is now an explicit selection criterion

Pre-DAP, sites were selected primarily on PI quality, patient flow, contracting speed, and indication fit. Demographic profile was a soft tiebreaker.

Post-DAP, demographic profile is a hard criterion. Sponsors ask:

• What is the demographic profile of the patient population the site sees in routine care?
• What is the demographic profile of the site's last 3 trial enrollments?
• What languages does the site operate in?
• Does the site have community ties to underrepresented populations the protocol needs to reach?

Sites with naturally diverse walk-in clinical flow have a structural advantage. Sites in highly homogeneous geographic areas are disadvantaged, regardless of historical PI quality.

2. Hispanic and Latino representation is a specific cardiovascular focus

Cardiovascular disease prevalence is high in Hispanic and Latino populations, and historical clinical trial enrollment has under-represented them. FDA reviewers pay attention to this gap. Sponsors planning DAPs for cardiovascular trials are explicitly setting Hispanic/Latino enrollment targets — and selecting sites that can hit them.

Miami-Dade County, where Amavita Research is located, is approximately 70% Hispanic/Latino per U.S. Census data. The Amavita Research patient catchment naturally produces Hispanic/Latino patient flow without artificial recruitment effort. This is structurally different from sites in less diverse geographies that would need to invest heavily in outreach to meet the same targets.

3. Site bilingual capacity is now a feasibility checkbox

DAP-compliant enrollment of Spanish-speaking patients requires Spanish-language informed consent forms, Spanish-speaking trial coordinators, Spanish-language patient-facing materials, and verifiable language capacity in the medical record. Sites without these capabilities can technically enroll Spanish-speaking patients but functionally produce higher screen-fail rates and higher protocol-deviation rates.

For Miami-Dade trials, multi-language capacity now extends past Spanish into Haitian Creole and Brazilian Portuguese for many sponsors.

4. Community trust is documented and audited

DAPs require sponsors to describe their patient-engagement strategy, and FDA reviewers increasingly ask for evidence (not just assertions) that sites have established trust with the populations they intend to enroll. Sites operating inside an active private cardiology practice — where patients have an existing care relationship before being approached about a trial — have demonstrable, documentable trust.

How sponsors should adjust site-selection strategy

Shift 1: Add demographic profile to your feasibility questionnaire

Race/ethnicity breakdown of routine-care patient population, race/ethnicity breakdown of last 3 trial enrollments, language capacity (verified, not just claimed), community partnerships and patient-trust evidence. Sites that can answer these specifically and back them up with documentation are DAP-ready. Sites that hedge are DAP-fragile.

Shift 2: Build your site portfolio for cumulative DAP performance, not site-by-site

A single site rarely produces a perfectly representative cohort. The portfolio is what produces DAP-compliant enrollment. Select for portfolio-level diversity. A site in Miami, a site in San Antonio, a site in Atlanta, a site in Philadelphia, a site in Phoenix — each contributing a different demographic profile.

Shift 3: Use Latin America arms strategically

For cardiovascular indications where Hispanic/Latino representation matters, a US + Latin America hybrid design (covered in our cross-border strategy guide) is one of the cleanest ways to produce regulatory-meaningful diversity data. FDA does accept pooled US + Latin America data when the DAP and statistical analysis plan are properly designed.

Shift 4: Document everything

DAPs aren't just an enrollment requirement — they're a documentation requirement. Sites that have ICH-GCP-aligned source-document workflows and demographic-capture infrastructure operationalize DAP requirements naturally. Sites without these need retrofit.

How Amavita Research operationalizes DAP requirements

For sponsors considering Amavita Research as part of a DAP-compliant cardiovascular trial portfolio:

• Patient demographic profile: The amavita Heart and Vascular Health® patient population reflects the Miami-Dade demographic mix. Approximately 70% of routine cardiology patients are Hispanic/Latino, with the remaining mix including non-Hispanic White, non-Hispanic Black, Haitian-American, and Brazilian-American patients.
• Language capacity: Bilingual English/Spanish staff at the PI, CRC, and patient-facing levels. Haitian Creole and Brazilian Portuguese supported at the patient-facing level.
• Consent infrastructure: Spanish-language ICFs prepared in-house for most active trials; sponsors providing ICFs in Spanish, Haitian Creole, and Brazilian Portuguese are supported.
• Community trust: Patients are seen in routine cardiology care first, trial-eligible patients are approached by the same physicians they already trust. No database recruitment for trial flow.
• Documentation: Source documents capture race/ethnicity/language at every visit per ICH-GCP. DAP-aligned reporting available to sponsors on request.

What this means for Phase 3 cardiovascular trial planning

If you're building a Phase 3 cardiovascular trial portfolio in 2026, the DAP isn't a checkbox at the end. It's a planning input from the first site-identification conversation.

This shifts the math on the three site archetypes:

• Academic medical centers: usually have diverse patient populations, but enrollment-rate variability and slower contracting still apply. DAP-friendly when activated.
• Network sites: variable. Some networks have demographically diverse portfolios; others are concentrated in homogeneous geographies. Verify at the network level.
• Independent investigator-led sites: as diverse as their geography. In Miami, Atlanta, Houston, the Bronx, etc., this is a structural advantage.

The right portfolio mixes archetypes geographically and demographically to produce a DAP-compliant cumulative cohort.

Practical next steps

If you're evaluating Amavita Research for a DAP-driven cardiovascular trial:

1. Send your DAP draft or your demographic targets with your protocol synopsis to our sponsor contact form. We respond with a documented demographic profile of recent enrollments and an indicative target for your specific protocol.
2. Request our DAP-aligned documentation package — a sponsor-facing summary of our race/ethnicity/language capture workflow and recent enrollment demographics.
3. Discuss a Latin America arm if Hispanic/Latino representation is a primary DAP focus.

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About the author: Julio G. Martinez-Clark is Head of Growth & Strategy at Amavita Research and CEO of bioaccess®, a Latin America first-in-human CRO.

Disclaimer: This article summarizes Amavita Research's understanding of FDA's Diversity Action Plan Final Guidance (June 2024). It is not legal or regulatory advice. Sponsors should consult their regulatory affairs team or FDA reviewers directly for guidance on specific submissions.