FDA Aims to Boost Diversity in Trials

A 27-point action plan by the FDA aims to boost participation by women, minorities, and older people in clinical trials in order to facilitate research and assist in clinical decision-making.

The 5-year plan includes working with industry, advocacy groups, and other stakeholders to standardize subgroup categories, develop strategies to attract participants, and improve the quality of subgroup analyses in new drug applications. At the same time, the agency published final guidance on evaluating sex-specific data in medical device studies in order to ensure that devices are analyzed for potentially different responses in men and women.

“We know that richer information is collected when different subgroups are enrolled in pivotal studies for medical products,” wrote FDA Commissioner Margaret Hamburg, MD, in a blog post. “This kind of enrollment in turn gives us greater assurance in the safety and effectiveness of the medical products used by a diverse population.”

The plan also calls for revising participation criteria for clinical trials to avoid restrictions that disproportionately exclude older patients, such as having an age limit of 65 for cardiovascular trials even though women often develop the disease later in life.

“The age cutoff may be confounding the process of trying to include more women in trials,” says Martha Nolan, JD, vice president of public policy for the Society for Women's Health Research in Washington, D.C. “Clinicians need that data to make appropriate treatment decisions for the many women who experience cardiovascular disease after age 65.”

Although she is pleased that the FDA developed the plan, Nolan says that some details have not been addressed.

“The plan doesn't spell out for applicant sponsors the consequences of not including or analyzing subgroup data,” she says. “It's especially important to address the underinclusion of women, minorities, and the elderly in early-phase drug trials, where dosing and efficacy are determined.”

The plan also fails to address the socioeconomic status of research participants, says Jennifer K. Walter, MD, PhD, assistant professor of pediatrics at the University of Pennsylvania Perelman School of Medicine in Philadelphia, who has studied factors affecting minority participation in research.

“The agency doesn't specify whether or not they will collect or how they would categorize socioeconomic data, but that could be another element in patients' willingness to participate in research,” Walter says.

The FDA should also examine the role of financial incentives in attracting more minority participants, she adds.

“Past research indicates that what people are paid is well below covering the costs for their time,” notes Walter. “It would be well worth collecting data on whether or not there is an ability to enroll minorities adequately with different levels of payment.”

A public workshop will be held in about 18 months to assess the FDA's progress toward implementing the action items.