The American Medical Association (AMA) has adopted a new policy aimed at increasing diversity in clinical trials and research to improve health outcomes. This policy urges the U.S. Food and Drug Administration (FDA) to require drug and device sponsors to develop actionable clinical trial diversity action plans that include women and Sexual and Gender Minority (SGM) populations. Additionally, it supports the FDA's efforts to condition drug and device approvals on post-marketing studies evaluating efficacy and safety for these groups when they were not adequately represented in initial 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," said AMA Board Member Toluwalase Ajayi, M.D. "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."
Under this new policy, the AMA will also encourage entities like the National Institutes of Health (NIH) to fund post-market research investigating pharmacodynamics and pharmacokinetics for generic drugs that did not adequately enroll women or SGM populations in their clinical trials. The priority will be given when these groups represent a significant portion of patients or reported adverse drug events.
The AMA Council on Science and Public Health report highlighted historical context for this issue, noting intense discussions about women's participation in clinical trials following birth defects caused by thalidomide in the 1950s. This led to amendments in the Food Drug and Cosmetic Act of 1962, resulting in today's phased clinical trial model. In 1977, regulations barred all women “of child-bearing age” from participating in most clinical trials due to fears of birth defects similar to those caused by thalidomide. Recognizing the impact of excluding women from trials on health equity, the FDA repealed this rule in 1993, mandating NIH-funded studies include women.
Despite regulatory changes since the 1990s aimed at improving diversity in clinical trials, inequities persist. One study suggests women experience adverse drug reactions approximately twice as often as men due to poor understanding of sex differences on pharmacokinetics stemming from low female participation in trials. An analysis of NIH-funded studies performed in 2015 revealed only 26 percent explicitly used sex as a variable; many with low female enrollment still generalized data across sexes.
SGM populations have also been underrepresented historically. Individuals identifying as gay, lesbian, transgender, gender non-binary, or gender expansive are often omitted entirely from clinical research categories despite being high-risk populations for certain conditions. For example, less than five percent of substance use disorder studies between 2007-2012 reported sexual orientation as a participant demographic.
“The lack of participation of women and SGM in clinical trials has clear impacts on the care these populations receive," said Dr. Ajayi. "Despite changes in the regulatory environment, inequities in clinical trial participation and outcomes persist today. We commend the FDA’s work to date and we are committed to furthering efforts to improve equity in patient outcomes.”
