The Food and Drug Administration has drafted guidance aimed at getting drug companies and medical device makers to enroll more people of color and women in the clinical trials that test whether products work.
The guidance is long-awaited. It’s the first step in carrying out a law that Congress passed in 2022, and it’s six months late. Congress sought to fix the chronic lack of diversity in clinical research by requiring that companies give the FDA their plans for enrolling patients who are representative of the patients who would take the products being tested.
When trials fail to include the people most affected by the diseases that a product treats, it undermines research and leaves doctors and patients without needed information for decisions about their health care, according to the National Institutes of Health.
The tardiness of the guidance delays the requirement for incorporating diversity into clinical trials, because the start date is six months after the FDA publishes the final version of the guidance.
What the agency issued Wednesday is draft guidance, and the public now has three months to give feedback on it, after which the agency will start writing the final version.
The draft guidance describes the format and content of so-called diversity action plans and the timing and process for submitting them. The diversity plans are required for large Phase 3 trials that typically test products against existing standards of care. The guidance also explains how to get waivers for the plans.
The plans are encouraged to include the rationale and goals for enrollment, separated by the age, ethnicity, gender, and race of the clinically relevant study populations. Companies also are supposed to explain how they’ll meet those goals.
Clinical trial diversity is key to the goal of making health care equitable, according to Arati Prabhakar, director of the White House Office of Science and Technology Policy. Speaking Wednesday at a White House event on trial diversity, Prabhakar said the United States has “unacceptable” health outcomes compared to other rich countries, and she lamented the vast inequities.
“We’re at a moment where we have to stare this in the face,” Prabhakar said.