Prioritizing women’s inclusion in clinical trials of medical devices (10 June 2024)

Summary

In this JAMA Internal Medicine article, doctors Jessica Holtzman and Rita Redberg argue that for decades, women have been inadequately represented in clinical trials of drugs and devices evaluated by the US Food and Drug Administration (FDA). Looking at existing evidence on the issue, they identify barriers and improvements to women's representation in trials. They argue that the FDA needs to take action by declining to review medical devices and drugs if the representation of women does not reflect the intended use population.