CHICAGO — Given the long history of medical devices and medications being developed without sufficient data on how they impact women, and sexual and gender minority (SGM) populations, the delegates at the Annual Meeting of the American Medical Association (AMA) House of Delegates adopted policy to ensure more women and SGM are included in clinical trials and medical research.

Furthering the AMA’s efforts to ensure diversity in clinical research to improve health outcomes, the new policy calls for the AMA to support the U.S. Food and Drug Administration (FDA) in requiring drug and device sponsors to develop actionable clinical trial diversity action plans that include women, and SGM populations. The new policy also supports the FDA’s efforts to condition drug and device approvals on post-marketing studies that evaluate the efficacy and safety of products in women and SGM populations, when those groups were not adequately represented in clinical trials.

“For too long, women and SGM populations largely have been excluded from clinical trials and medical research—leading to unnecessary health inequities and negatively impacting the care these populations receive. To ensure that medications and medical devices are developed based on research that reflects their unique needs, we must increase the participation of women and SGM populations, as well as actively support the involvement of both women and SGM researchers in clinical research,” said AMA Board Member Toluwalase Ajayi, M.D. “Without this important data, there’s no way to know whether medications and medical devices are not only safe, but effective, for use in women and SGM populations.”

Under the new policy, the AMA will also support and encourage the National Institutes of Health, and other grant-making entities, to fund post-market research investigating pharmacodynamics and pharmacokinetics for generic drugs that did not adequately enroll women, and SGM populations in their clinical trials—prioritizing instances when those populations represent a significant portion of patients or reported adverse drug events.

The AMA Council on Science and Public Health report that served as the basis for this policy noted that women participating in clinical trials became a topic of intense discussion in the United States and Europe after birth defects caused by the medication thalidomide were discovered in the 1950s. This led to an amendment to the Food Drug and Cosmetic Act of 1962, resulting in the phased clinical trial model used today. FDA then introduced regulations in 1977 barring all women “of child-bearing age” from participating in clinical trials outside of life-saving drugs due to fears of birth defects from a similar medication to thalidomide. In 1993, recognizing the impact that excluding women from clinical trials had on health equity, the FDA repealed their 1977 rule and Congress passed a mandate that all studies funded by NIH include women and assess differences amongst sexes. Since the 1990s, the FDA has been committed to improving diversity in clinical trials. The AMA’s new policy serves to strengthen the FDA’s efforts and ensure more women and SGM are included in clinical trials and medical research.

One study suggests women experience adverse drug reactions approximately twice as often as men, a result of  women’s lack of participation in clinical trials leading to poor understanding of the influence of sex on pharmacokinetics. Additionally, an analysis of NIH-funded clinical trials performed in 2015 showed that only 26 percent of studies explicitly used sex as a variable in their analysis, 72 percent made no mention of sex at all, and many studies with low enrollment of women still represented their data to suggest that it is generalizable across sexes.

The AMA Council on Science and Public Health report also noted that participation of SGM populations in clinical trials is less representative of the population—with individuals identifying as gay, lesbian, transgender, gender non-binary, or gender expansive, having been historically omitted entirely as a category for clinical research, even when they are a high-risk population. For example, despite a higher risk of substance use disorders in people identifying as gay or lesbian, one analysis found that less than 5 percent of substance use disorder studies from 2007 to 2012 reported sexual orientation as a relevant participant demographic.

“The lack of participation of women and SGM in clinical trials has clear impacts on the care these populations receive. Despite changes in the regulatory environment, inequities in clinical trial participation and outcomes persist today,” said Dr. Ajayi. “We commend the FDA’s work to date and we are committed to furthering efforts to improve equity in patient outcomes.”

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