Clinical Research: Phase 1 - Phase 4

FDA’s Diversity Mandate: Transforming Clinical Trials and Drug Development for Better Outcomes for All

On June 26, 2024, the U.S. Food and Drug Administration (FDA) released its much-anticipated draft guidance on clinical trial diversity.1 This 23-page document outlines proposed requirements for racial and ethnic diversity action plans, which will soon become mandatory for studies involving drugs, devices, and other medical products. In this article, we highlight the key provisions of the guidance and their implications for clinical development professionals.

Advancing Diversity in Clinical Trials: FDA’s Vision and Goals

The draft guidance, developed by the FDA’s Oncology Center of Excellence in collaboration with various FDA centers and offices, underscores the agency’s broader goals of ensuring diverse patient cohorts in clinical trials. It emphasizes the need for sponsors to consider demographic characteristics such as race, ethnicity, sex, and age group when setting enrollment goals. The guidance recommends looking beyond these factors to include socioeconomic status, geographic location, and comorbidities to ensure a comprehensive understanding of the product’s performance.

FDA Commissioner Robert M. Califf, M.D., emphasized the importance of this initiative:

“Participants in clinical trials should be representative of the patients who will use the medical products. The agency’s draft guidance is an important step – and one of many ongoing efforts – to address the participation of underrepresented populations in clinical trials to help improve the data we have about patients who will use the medical products if approved.”1

Essential Components of the FDA’s Draft Guidance

The draft guidance document provides detailed instructions on the structure and content required for diversity action plans and submission guidelines.2 Here are the main components:

  1. Enrollment Goals: Companies must set specific recruitment targets for various racial and ethnic groups, stratified by age and gender
  1. Rationale: Sponsors must provide a clear rationale for these goals, based on the epidemiology of the condition the product aims to treat
  1. Implementation Strategies: The guidance outlines several approaches to meet diversity goals, including:
  1. Transparency: Sponsors are encouraged to publicize their recruitment strategies

Applicability and Compliance Requirements

FDA Commissioner Califf highlighted the critical role of the National Institutes of Health (NIH) in setting the precedent for clinical trial diversity and noted the FDA’s commitment to catching up and enforcing these new standards. Califf stressed the importance of planning for diverse enrollment early in the clinical trial process and considering various factors that influence trial participation.

According to the draft guidance, diversity action plans will be mandatory for:

  • Phase 3 trials
  • Other pivotal clinical drug studies
  • Investigational device exemption (IDE) applications
  • Clinical studies expected to form the primary basis for FDA approval of devices not requiring an IDE

Next Steps

To ensure that stakeholders can provide input on the FDA’s draft guidance on diversity in clinical trials, the agency has outlined a process for public comments and subsequent steps for implementation.

Public Comment Period: The public can submit comments on the draft guidance until September 25, 2024. Comments should be submitted online at under docket number FDA-2021-D-0789. All comments should reference the docket number and the title of the guidance document.

Implementation Timeline: FDA must issue final guidance within 9 months after the comment period closes. Following the publication of the final draft, all companies initiating patient enrollment 180 days thereafter will be required to submit their diversity action plans. This requirement applies to Phase 3 trials, other pivotal clinical drug studies, IDE applications, and clinical studies expected to form the primary basis for FDA approval of devices not requiring an IDE.

Key Takeaways

This draft guidance is a significant step in the FDA’s commitment to fostering diversity in clinical trials. Addressing the underrepresentation of diverse populations may enhance the validity and reliability of studies on the safety and efficacy of medical products. As clinical development professionals, understanding and implementing these guidelines is essential to improve outcomes for all patients.

By implementing comprehensive diversity action plans, the industry can work towards more inclusive research and potentially improve healthcare outcomes for all populations. Premier Research is here to help you respond, navigate, and implement the new FDA guidance on clinical trial diversity. Contact us today to ensure your studies meet these important standards and advance inclusive research.

[1] U.S. Food and Drug Administration. (2024, June 26). FDA guidance provides new details on diversity action plans required for certain clinical studies [Press release].

[2] U.S. Food and Drug Administration. (2024). Diversity action plans to improve enrollment of participants from underrepresented populations in clinical studies: Draft guidance for industry.