On June 26, 2024, the FDA issued new draft guidance describing the format and content, medical products, clinical studies, timing, and process for submitting diversity action plans. Likewise, the criteria and process by which the FDA will evaluate sponsors’ requests for exemption from this requirement.
This guidance is a response to the FDORA Act of 2022, which requires the FDA to update or issue guidance related to the format and content of Diversity Action Plans. Specifically, FDORA requires the FDA to report diversity metrics in 2024 publicly.
Comments on the draft guidance are due September 26, 2024
Diversity Action Plans are intended to increase enrollment of participants from historically underrepresented populations to help improve the data the agency receives about patients who can potentially use the medical product. The plan does not focus on “the numbers but on the representation rate of historically underrepresented populations based on race, ethnicity, sex, and age.”
Here are some of the key points from the draft guidance:
Importance of diversity:
Diverse participation in clinical studies ensures that data reflects the diverse populations using medical products, leading to more effective and safer treatments in different demographic groups.
Registration Challenges:
- Historically, underrepresented populations, including racial and ethnic minorities, women, older people, and people with comorbid conditions, have been significantly less included in clinical trials.
- Barriers include lack of awareness, mistrust, logistical problems, and eligibility criteria that may inadvertently exclude certain groups.
What Clinical Studies Require Action Plans for Diversity?
The action plans apply to Phase 3 clinical studies or, as appropriate, other pivotal clinical studies of a drug or biological product, as well as specific device clinical studies, including those intended to serve as the primary basis for the evaluation of the FDA of the safety and effectiveness and the determination of the risk-benefit ratio of the device. The requirement to submit a Diversity Action Plan applies to any clinical study for which enrollment begins 180 days after publication of the final guidance.
Diversity Action Plans (DAP):
- According to the guidance, Diversity Action Plans should specify the sponsor’s rationale and objectives for clinical trial enrollment (separated by age group, ethnicity, sex, and race of the clinically relevant study populations) and describe how the sponsor intends to meet those objectives.
- DAPs should outline specific strategies to enroll and retain participants from underrepresented populations.
- These plans should be part of the early stages of development and continue throughout the study.
- The guidance also encourages sponsors and investigators to consider the many dimensions of clinical trial diversity, including those that extend beyond age, ethnicity, sex, and race, to enroll populations that are representative of patients. If the product is approved, that will be addressed.
DAP components:
- Enrollment Goals: The plan should have clear and measurable goals to include diverse populations.
- Community Engagement: Sponsors and sites must build strategies to build trust and long-term partnerships with community organizations and local healthcare providers. These partnerships should go beyond individual trials and create a sustainable infrastructure for ongoing community engagement and participation in clinical research.
- Resource Allocation: Both sites and sponsors must allocate more resources to support participants from diverse backgrounds. This may include providing transportation, child care, and financial assistance to remove socioeconomic barriers to participation, which will place additional demands on study teams and budgets.
- Flexible and inclusive protocols: Sponsors should review clinical trial protocols to make them more flexible and inclusive. Including re-evaluation of eligibility criteria to avoid exclusions
- Training and education: The industry must conduct regular training sessions for clinical trial staff on cultural competency and the importance of diversity in clinical research. This training should emphasize the ethical and scientific reasons for inclusive trials and provide practical strategies to achieve them.
Modification of Diversity Action Plans (DAP):
Diversity Action Plans may be modified in response to FDA comments or under the sponsor’s initiative. If the objectives of the original plan are not met, the current guidance only suggests an explanation be provided. “If such objectives are not met or are not expected to be met by the end of the study, the status report must include a description of the reasons why the sponsor is not currently meeting and/or does not expect to meet the enrollment objectives and the sponsor’s plan to mitigate such outcome,” the guidance says (lines 596-599).
Monitoring and reporting:
Robust data collection and reporting: Sponsors must implement systems for rigorous data collection and reporting on diversity metrics. Sponsors must track and publicly report their progress toward achieving diversity goals, including any barriers encountered and how they were addressed. This increased transparency is designed to hold sponsors accountable and share best practices across the industry.
Regulatory considerations:
- Sponsors should contact the FDA early and often to discuss their EPDs.
- The FDA can provide comments and require modifications to ensure that plans are robust and effective.
Through this guidance, the FDA aims to improve the relevance and generalizability of clinical study results, ultimately leading to better health outcomes for all populations. To fully comply with these recommendations and achieve the desired impact, sponsors and sites will need to implement several operational changes, including the use of technology.
This includes using telehealth for consultations, electronic tools for recruitment and data collection, mobile health applications to reduce the need for frequent in-person visits, and remote monitoring to maintain supervision in multiple locations at once. If you need help implementing technology on your clinical trials contact us here.
You can access the draft guidance on the FDA website here for more detailed information. (Diversity Action Plans to Improve Enrollment of Participants from Underrepresented Populations in Clinical Studies | FDA)
Key Points
New FDA Guidelines: The FDA issued draft guidance on Diversity Action Plans, detailing their format, content, and the submission process.
Inclusion Requirements: Diversity Action Plans apply to Phase 3 clinical studies and other pivotal studies, aiming to increase the participation of historically underrepresented populations.
Key Components of DAPs: Plans must include clear enrollment goals, community engagement strategies, resource allocation, and flexible, inclusive protocols.
Monitoring and Reporting: Sponsors must implement robust systems for collecting and reporting diversity data and publicly report their progress and challenges.
Collaboration with the FDA: Sponsors are encouraged to maintain ongoing communication with the FDA to ensure that Diversity Action Plans are effective and meet regulatory expectations.
