AMA adopts new policy to ensure diversity in clinical trials and research

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The Annual Meeting of the American Medical Association (AMA) House of Delegates has adopted a new policy to ensure more women and sexual and gender minority (SGM) populations are included in clinical trials and medical research.

According to the AMA, the new policy calls for the organization to support the US Food and Drug Administration (FDA) in requiring drug and device sponsors to develop clinical trial diversity action plans that include women, and sexual and gender minority populations.¹

Toluwalase Ajayi, MD, an AMA board member commented on the new policy and the impact it could have in a release from the organization.

“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 Ajayi. “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.”

According to the AMA, under the new policy, it will encourage grant-making entities, such as the National Institutes of Health (NIH) and others, 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.¹ The organization said it will prioritize encouragement in instances where women, and sexual and gender minority populations represent a significant portion of patients or reported adverse drug events.

The AMA Council on Science and Public Health report gave insight on some of the history of women in clinical trials in the United States as well.¹

In the 1950s it was discovered that birth defects were caused in children carried by women who participated in a clinical trial of thalidomide. This discovery led to an amendment to the Food Drug and Cosmetic Act of 1962, which resulted in the phased clinical trial that is still used to this day.

In 1977 further regulations were introduced by the FDA which barred women of a “child-bearing age” from participating in clinical trials, apart from life-saving drugs. This was done out of concern for birth defects from a similar medication to thalidomide. This ruling was repealed in 1993 after realizing the impact that excluding women from clinical trials would have on health equity. Thus, Congress passed a mandate that all studies funded by NIH were to include women and assess differences amongst sexes.

A study conducted in 2020 by Irving Zucker, Department of Psychology, University of California and Brian J Prendergast, Department of Psychology and Committee on Neurobiology, University of Chicago, suggested that women may suffer from adverse drug reactions approximately twice as much as men do.² Suggesting that lack of participation in clinical trials from women is leading to poor understanding of the influence of sex on pharmacokinetics.²

A further analysis of NIH-funded clinical trials performed in 2015 showed only 26% of studies explicitly used sex as a variable in their analysis, 72% 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.¹

Furthermore, the AMA Council on Science and Public Health report notes that participation of SGM populations in clinical trials is less representative of the population. Individuals identifying as gay, lesbian, transgender, gender non-binary, or gender expansive have been historically omitted entirely as a category for clinical research, even when they are a high-risk population.

Despite a higher risk of substance use disorders in people identifying as gay or lesbian, one analysis, cited by AMA, found that less than 5% of substance use disorder studies from 2007 to 2012 reported sexual orientation as a relevant participant demographic.³

References:

1. AMA adopts new policy to create equity in clinical trials and research. Press Release; June 11, 2024. Accessed June 13, 2024. https://www.ama-assn.org/press-center/press-releases/ama-adopts-new-policy-create-equity-clinical-trials-and-research#:~:text=Furthering%20the%20AMA's%20efforts%20to,that%20include%20women%2C%20and%20SGM

2. Zucker I, Prendergast BJ. Sex differences in pharmacokinetics predict adverse drug reactions in women. Biol Sex Differ. 2020 Jun 5;11(1):32. doi: 10.1186/s13293-020-00308-5. PMID: 32503637; PMCID: PMC7275616.

3. Flentje A, Bacca CL, Cochran BN. Missing data in substance abuse research? Researchers' reporting practices of sexual orientation and gender identity. Drug Alcohol Depend. 2015 Feb 1;147:280-4. doi: 10.1016/j.drugalcdep.2014.11.012. Epub 2014 Nov 26. PMID: 25496705; PMCID: PMC4297716.