AMA: Drug, device sponsors need to include women, LGBTQ+ patients in trials
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Key takeaways:
- The lack of diversity in clinical trials has led to substantial health inequities.
- A new policy advocates for more data on drugs and devices in women and the LGBTQ+ community.
The AMA announced a new policy that supports requirements for drug and device sponsors to develop diversity action plans so that women and sexual and gender minorities are adequately represented in their clinical trials.
The policy also backs efforts from the FDA to condition the approval of drugs and devices on postmarketing research that includes safety and efficacy data on women and sexual and gender minorities (SGM) when these groups were not amply represented in the clinical trials, according to a press release.
Additionally, the policy encourages the NIH and other grantmakers to fund postmarketing research that investigates the pharmacodynamics and pharmacokinetics of generic drugs with limited data on women and SGM populations.
“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,” AMA Board Member Toluwalase Ajayi, MD, said in the release. “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.”
The AMA cited a 2020 study that showed adverse drug reactions occur twice as often in women than in men, “a result of women’s lack of participation in clinical trials leading to poor understanding of the influence of sex on pharmacokinetics,” the release said. Another analysis revealed that only 26% of NIH-funded trials used sex as a variable and 72% did not even mention sex. In addition, many trials with low female representation still indicated that the findings were generalizable across sexes.
The AMA further noted that, historically, research has excluded SGM as a category, even when these patients are considered high risk. For example, one study found that less than 5% of trials on substance use disorders from 2007 to 2012 reported on sexual orientation, despite the greater risk for substance use disorders in SGM populations.
“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,” Ajayi said. “We are committed to furthering efforts to improve equity in patient outcomes.”
References:
- AMA adopts new policy to create equity in clinical trials and research. https://www.ama-assn.org/press-center/press-releases/ama-adopts-new-policy-create-equity-clinical-trials-and-research. Published June 11, 2024. Accessed June 11, 2024.
- Flentje A, et al. Drug Alcohol Depend. 2015;doi:10.1016/j.drugalcdep.2014.11.012.
- Waltz M, et al. J Womens Health. 2021;doi:10.1089/jwh.2020.8674.
- Zucker I, Prendergast BJ. Biol Sex Differ. 2020;doi:10.1186/s13293-020-00308-5.
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