Upholding Equity in Clinical Research

By implementing structured Diversity Action Plans and supportive policies, the FDA and AMA aim to foster more inclusive clinical trials and ensure that medical products are safe and effective for all populations.

The FDA

In June 2024, the U.S. Food and Drug Administration (FDA) issued draft guidance titled “Diversity Action Plans to Improve Enrollment of Participants from Underrepresented Populations in Clinical Studies.” This guidance assists medical product sponsors in submitting Diversity Action Plans to increase the participation of historically underrepresented groups in clinical trials. The FDA emphasizes that participants should reflect the patient’ demographics who will use the medical products, thereby improving the applicability and safety of treatments across diverse populations. U.S. Food and Drug Administration

The AMA

Complementing the FDA’s efforts, the American Medical Association (AMA) adopted a new policy in June 2024 to ensure greater inclusion of women and sexual and gender minority (SGM) populations in clinical trials and medical research. This policy supports the FDA’s requirement for sponsors to develop actionable Diversity Action Plans and conditions for drug and device approvals on post-marketing studies that evaluate efficacy and safety in these populations. The AMA highlights the historical underrepresentation of these groups in clinical research, which has led to health inequities and compromised care quality.
American Medical Association

Summary: Diversity Action Plans to Improve Enrollment of Participants
from Underrepresented Populations in Clinical Studies.

The plan’s goal is to ensure that clinical study populations more accurately reflect the demographics of the intended use population, thereby improving the generalizability and applicability of study results.

According to the guidance, DAPs should include specific enrollment goals categorized by race, ethnicity, sex, and age group, along with the rationale for these targets and strategies to achieve them. The requirement to submit DAPs applies to certain clinical studies for drugs and devices, particularly phase 3 or pivotal studies, with enrollment commencing 180 days after the final guidance is published. Sponsors are encouraged to discuss their DAPs with the FDA early in the development process to ensure alignment with regulatory expectations.

The FDA emphasizes that enhancing diversity in clinical studies is crucial for detecting potential differences in product performance across various populations and ensuring medical products’ safety and effectiveness for all intended users. The guidance also outlines the process for sponsors to request waivers from the DAP requirement, although such waivers are expected to be granted only in rare circumstances. By implementing these plans, the FDA aims to address health disparities and promote equity in clinical research.

Providing clinical trial study participants with flexible payment options is crucial for promoting inclusivity and ensuring diverse representation in research. Participants from underrepresented populations often face unique financial and logistical challenges, such as lack of access to traditional banking systems, immediate reimbursement needs for travel or childcare, or cultural preferences for specific payment methods. Flexible options, such as digital wallets, direct payments, or regionally relevant gift cards, remove these barriers by catering to individual needs and preferences. This approach reduces participation drop-off and fosters trust and engagement, ensuring that trials more accurately reflect the populations that will ultimately use the medical products. By prioritizing flexibility in compensation, researchers can align their practices with diversity initiatives and uphold equity in clinical research.