The Food and Drug Administration (FDA) is seeking to diversify clinical trial participation and to have a more precise description and understanding of those who participate.
The agency’s proposed strategy to promote more equitable inclusion in clinical trials was praised by AMA Executive Vice President and CEO James L. Madara, MD, as “an important step forward” that would ultimately “improve health care outcomes for all.” The FDA issued its draft guidance for industry last summer.
In a comment letter (PDF) to FDA Commissioner Robert M. Califf, MD, Dr. Madara commended the FDA “for recognizing the critical importance of diversity in ensuring that clinical study outcomes are broadly applicable to the entire population.”
What more could be done
Dr. Madara also offered several recommendations to strengthen the effectiveness of the FDA’s diversity-action plans. His suggestions focus on:
- Refining enrollment goals through better data collection.
- Fostering enhanced priority population engagement.
- Ensuring a long-term commitment to diversity throughout the clinical trial process and beyond.
This includes having the FDA align with newly revised statistical policy directives that the AMA had recommended and were incorporated by the Office of Management and Budget (OMB).
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These revisions include the disaggregation of data that would enable clinical trial sponsors to analyze differences between various specific groups. The letter notes that disaggregating data within broader groups such as Asian or American Indian/Alaska Native “would allow for more precise representation of specific ancestral, national, cultural or tribal groups.”
The OMB, for example, added “Middle Eastern or North African” as a new category and said it was “encouraging respondents to select as many options as apply to how they identify.”
In previous correspondence (PDF), Dr. Madara told the commissioner that “the AMA believes that the FDA should provide clear instructions for respondents to ‘Select all categories that apply’ to allow people to self-report all aspects of their identity.” A lack of specific instructions on that score has led “Some Other Race” to become the second-largest racial group in the 2020 U.S. Census, and it included millions of people of Hispanic or Latino origin.
Dr. Madara’s recent letter noted that, under the broader classification of “Asian,” clinical trial applicants could add “Chinese” or “Korean,” and under the “American Indian/Alaskan Native” umbrella, applicants could further distinguish themselves by adding “Lakota” or “Navajo Nation.”
“This approach would also promote transparency, as public reporting of disaggregated data can provide a clearer and more accurate picture of the diversity achieved in clinical trials,” the letter says.
The AMA has detailed policy, last updated in 2022, on increasing equitable inclusion in clinical trials.
Long-term commitment needed
The AMA recommended that the FDA encourage clinical trial sponsors to include community leaders, patient advocacy groups, local health organizations and other interested parties early in the trial design process.
Dr. Madara noted that these stakeholders would bring valuable insights and help foster trust and address misconceptions about the research process and that the commitment to diversity should extend beyond clinical trials to post-marketing surveillance.
“It is equally important to monitor how these therapies perform across different demographic groups after regulatory approval and market introduction,” the letter says. “We encourage FDA to consider what available actions it can take to promote a culture within the industry where diversity and inclusion become integral to clinical research.”
Diversification of health innovation—including clinical trials—is a key action for the pharmaceutical, biotechnology and research organizations participating in the Rise to Health Coalition, which was launched last year by the AMA, the Institute for Healthcare Improvement and numerous other partners. The coalition aims to help physicians and health care organizations take coordinated actions that have a strong national impact in advancing health equity.
Learn about the AMA Center for Health Equity and the AMA’s 2024—2025 strategic plan to advance health equity.
