Diversity in clinical trials is now mandated by law. While the importance of study diversity has long been emphasized, this marks the first time it has been codified into law under the Food and Drug Omnibus Reform Act of 2022 (FDORA).1 Through diversity action plans, this requirement is designed to increase the inclusion of underrepresented populations in pivotal clinical research.
Ensuring that clinical trials reflect the diverse populations who will ultimately use a drug or device is not just a scientific imperative; it’s a moral one. Historically, certain racial, ethnic, and age groups have been severely underrepresented in clinical research. This has led to health disparities, mistrust in the system, and medical products that may not work equally well for all patients. A robust Diversity Action Plan (DAP), required in Section 3601 of FDORA,1 is a critical step in addressing these gaps.
In this blog, we explore the six core components of a DAP. We offer examples and suggestions for sponsors and share insights to help you navigate compliance while building more equitable and effective studies.
Regulatory Context and Industry Guidance
Section 3602 of FDORA requires the FDA to issue or update guidance on diversity action plans. The FDA’s most current guidance—released in June 2024—provides sponsors with detailed recommendations on what to include in a DAP and how to align it with trial design and protocol development.2
These plans may help ensure that sponsors are thinking critically and intentionally about the many characteristics of the patient population they aim to treat when designing their clinical study.”
— Dr. Richard Pazdur, Director, FDA Oncology Center of Excellence3
Though still in draft form, the guidance reflects the FDA’s current thinking and serves as a benchmark for proactive sponsors preparing Phase 3 submissions. The compliance deadline for mandatory submission of DAPs is 180 days after the final FDA DAP guidance is issued.
In January 2025, Robert F. Kennedy Jr. told U.S. senators during his confirmation hearing for the position of U.S. Department of Health and Human Services Secretary, which oversees the FDA, that he would finalize the FDA’s guidance on increasing clinical trial diversity. However, he did not commit to a specific timeline or guidance content.
What Is a Diversity Action Plan (DAP)?
A Diversity Action Plan is a formal document submitted to the FDA as part of the regulatory package for most Phase 3 and pivotal clinical trials. It outlines how the sponsor will ensure that clinical trial participants reflect the demographics of the population most likely to use the investigational product. These plans promote the inclusion of historically underrepresented populations based on race, ethnicity, sex, age, geography, and other factors.
By establishing and executing these plans early in trial design, sponsors fulfill regulatory expectations. And they also improve clinical study integrity and public trust.
6 Key Components of Diversity Action Plans
1. Enrollment Goals
Sponsors must set clear, measurable targets for the enrollment of participants from diverse demographic groups—particularly by race, ethnicity, age, and sex.
2. Justification of Goals
These enrollment goals must be supported by relevant scientific, demographic, or public health data about the disease condition and its prevalence.
3. Recruitment Strategies
DAPs must outline how sponsors will reach and engage diverse populations. This often requires tailored outreach and community engagement along with diversity training for study personnel.
4. Retention Strategies
Enrollment is only half the equation. Retaining participants from underrepresented populations is equally essential to trial integrity.
5. Monitoring and Reporting
The plan should explain how sponsors will track their progress toward enrollment targets. This should include an expectation to adjust mid-trial tactics if goals are not being met.
6. Site Selection Considerations
ClinicalTrials.gov is a valuable resource. It allows sponsors to review enrollment patterns from past trials, identify locations where diverse populations have been successfully recruited, and benchmark study designs.4
Final Thoughts
The implementation of Diversity Action Plans marks a watershed moment in clinical research. By elevating diversity from an ethical aspiration to a regulatory requirement, the FDA is reinforcing the need for inclusive science that reflects real-world populations.
Sponsors who take this seriously will do far more than just check a box. They will build more robust data sets, reduce bias, and increase credibility with regulators. Most importantly, they will develop therapies that serve all patients, not just a subset.
How Imperial Supports Implementation of Diversity Action Plans
While sponsors are responsible for developing and submitting Diversity Action Plans, Imperial Clinical Research Services offers operational support to help carry out the goals outlined in those plans. We don’t craft or author DAPs. But we do support the practical implementation of outreach, communication, and logistics strategies that help make diversity targets achievable.
Patient-Facing Materials
We develop and distribute print and digital culturally diverse and multilingual patient materials. These include consent form overview presentations, visit instructions, and engagement tools to help improve understanding, enrollment, and retention.
Translation and Localization Services
Imperial provides certified translation and cultural adaptation services for study documents and materials. These support participants whose first language isn’t English and reduce barriers to access.
Global Logistics and Material Distribution
We deliver clinical trial materials—including patient kits and site supplies—to a wide network of trial locations, including geographically diverse or underserved areas often central to DAP recruitment goals.
Custom Kitting Services
Our team builds patient and site kits that are tailored to the population, including translated components or culturally relevant instructions that align with DAP implementation.
Retention and Engagement Tools
We offer materials that support participant engagement and continuity—appointment reminders, diaries, or educational content—to help reduce dropout rates, especially in underrepresented communities.
Imperial’s flexible, experienced infrastructure enables sponsors to carry out the logistics and communication strategies necessary for DAP success, all while supporting regulatory compliance and trial inclusivity. Contact us for more information on how we can help with your clinical trial.
This blog is part of a 2-part series. Check out: The Upcoming FDA Clinical Trial Diversity Mandate: What You Need to Know.
References
- U.S. Congress. Food and Drug Omnibus Reform Act of 2022. #2697 New FDAR white paper- The Food and Drug Omnibus Reform Act of 2022 (FDORA)_B
- U.S. Food & Drug Administration. Diversity Action Plans to Improve Enrollment of Participants from Underrepresented Populations in Clinical Studies (Draft Guidance, June 2024).
https://www.fda.gov/regulatory-information/search-fda-guidance-documents/diversity-action-plans-improve-enrollment-participants-underrepresented-populations-clinical-studies - Reuters. US FDA Issues Guidance for Drugmakers on Diversity in Clinical Studies.
https://www.reuters.com/business/healthcare-pharmaceuticals/us-fda-issues-guidance-drugmakers-diversity-studies-2024-06-26 - ClinicalTrials.gov. Searchable Trial Demographics Database.
https://www.clinicaltrials.gov