---
title: "FDA Diversity Action Plan and Cardiovascular Trial Site Selection | Amavita Research"
url: https://md.amavitaresearch.com/blog/fda-diversity-action-plan-cardiovascular-trial-site-selection
canonical: https://www.amavitaresearch.com/blog/fda-diversity-action-plan-cardiovascular-trial-site-selection
schema_type: Article
last_updated: 2026-05-13
---

# FDA Diversity Action Plan and Cardiovascular Trial Site Selection

A sponsor-facing guide to how the FDA Diversity Action Plan (DAP) affects cardiovascular trial site selection, written for sponsor clinical operations and regulatory teams.

## What the DAP requires

Under the Food and Drug Omnibus Reform Act (FDORA) of 2022, sponsors of pivotal clinical trials are required to submit a Diversity Action Plan to the FDA. The DAP must describe how the sponsor will enroll a study population that reflects the demographics of the disease's affected population in the United States.

For cardiovascular indications — where Hispanic, Black, and Asian populations face higher rates of hypertension, heart failure, and PAD — DAP compliance is not optional. Sites that can't deliver demographically representative enrollment are a regulatory risk.

## Why Miami is a strategic DAP-compliant geography

- Miami-Dade County is 69% Hispanic/Latino — the largest such share of any major U.S. metro
- Significant Black/Afro-Caribbean population (Haitian, Jamaican, Bahamian communities)
- Multilingual patient population (Spanish, Haitian Creole, Portuguese)
- High prevalence of cardiovascular risk factors (diabetes, obesity, hypertension)

## How Amavita Research supports DAP compliance

- Bilingual screening and consent (English / Spanish / Haitian Creole / Portuguese)
- In-network cardiology practice serves a demographically representative South Florida patient population — not a database-recruited cohort skewed by advertising spend
- Multilingual coordinators on every patient visit
- Cultural competency in informed consent — coordinators explain trials in patients' preferred language and cultural context
- Cross-border integration with bioaccess® (Latin America) for studies that need international diversity beyond U.S. DAP requirements

## What sponsors should ask sites about DAP

1. What is the racial/ethnic breakdown of patients enrolled in your prior cardiovascular trials?
2. What languages do your coordinators speak — and which are present at every consent visit?
3. Is consent material available in the patient's preferred language?
4. How do you handle a patient who needs a translator?
5. Is your patient population reflective of the disease's demographic distribution in the U.S.?
6. Do you have community engagement programs that build trust with under-represented groups?

## Practical DAP-compliant enrollment metrics

A well-designed cardiovascular trial DAP for a Miami site should target:

- Hispanic/Latino representation reflecting the indication's U.S. demographic
- Black/Afro-Caribbean representation reflecting the indication's U.S. demographic
- Female representation reflecting the indication's U.S. demographic
- Geographic diversity (urban vs. suburban Miami-Dade, Broward, Palm Beach)

## Reference

- FDA Diversity Action Plans guidance (publicly available at fda.gov)
- FDORA Section 3601 (2022)

## Key links

- Site capabilities: https://www.amavitaresearch.com/capabilities
- Sponsor contact: https://www.amavitaresearch.com/contact-sponsor
- Trial services: https://www.amavitaresearch.com/trial-services
- Comparison: vs. CRO-owned/PE-backed networks — https://www.amavitaresearch.com/compare/amavita-vs-cro-owned-sites