The FDA’s Diversity Plans and TMF Compliance: What You Need to Know

July 18, 2024

The FDA’s recently released draft guidance, “Diversity Action Plans to Improve Enrollment of Participants from Underrepresented Populations in Clinical Studies,” outlines essential requirements for increasing diversity in clinical trials. While the primary focus is on promoting inclusivity, several elements are directly relevant to the Trial Master File (TMF). This article highlights the critical aspects that TMF professionals need to consider to ensure compliance and inspection readiness.

1. Documentation of Diversity Action Plans (DAPs)

The FDA mandates that sponsors develop and submit Diversity Action Plans for certain clinical studies. These plans must include detailed enrollment goals, rationale, and strategies to achieve them. For TMF professionals, this means:

  • Inclusion of DAPs in the TMF: Ensure that all DAP-related documents are accurately filed within the TMF. This includes initial submissions, amendments, and any correspondence with the FDA.
  • Accessibility: Maintain these documents in an organized manner, making them readily accessible for inspections and compliance reviews.

2. Key Elements of Diversity Action Plans

Enrollment Goals: Sponsors must document specific goals for the enrollment of participants, disaggregated by race, ethnicity, sex, and age group. This documentation should be precise and aligned with the overall objectives of the clinical study.

  • TMF Best Practice: Include detailed records of the demographic targets and any supporting data used to set these goals. Ensure that any changes to these goals are also documented and filed.

Rationale for Enrollment Goals: The rationale for these goals must be thoroughly documented, including prevalence and incidence estimates of the disease or condition within the target population.

  • TMF Best Practice: Store all background information and analyses that justify the enrollment goals. This includes epidemiological data, literature reviews, and expert consultations.

Measures to Meet Enrollment Goals: The DAP must outline the strategies and actions taken to achieve the enrollment targets, such as community engagement and participant support measures.

  • TMF Best Practice: File detailed plans and records of all implemented strategies, including training programs for staff, community outreach activities, and measures to reduce participant burden (e.g., transportation assistance, flexible study visit hours).

3. Compliance and Monitoring

Sponsors are required to monitor their progress toward meeting enrollment goals and document any adjustments made to their strategies.

  • TMF Best Practice: Regularly update the TMF with progress reports, monitoring data, and any modifications to the DAP. Ensure that these updates are timely and reflect the latest actions taken to stay on track with enrollment goals.

4. Submission Timelines

For drug studies, the DAP must be submitted with the Investigational New Drug (IND) application before the phase 3 study protocol submission.

  • TMF Best Practice: Maintain a timeline and checklist to track submission deadlines and ensure that all required documents are filed on time. This includes initial DAP submissions and any subsequent updates.

5. Public Disclosure

The FDA encourages sponsors to publicly disclose key information from their DAPs, enhancing transparency and accountability.

  • TMF Best Practice: Ensure that any publicly disclosed information is also filed within the TMF. This helps maintain a comprehensive record of all communications and disclosures related to the clinical study.