A Journal of the American Medical Association article encourages FDA to return device applications to companies that have not enrolled sufficient numbers of women or justified under-representation of women in their clinical studies for the devices.
The article, "Evaluating Sex Differences in Medical Device Clinical Trials," says such a step would help ensure a device has been evaluated in both women and men before it can receive approval.
The authors, Sanket S. Dhruva, MD, and Rita F. Redberg, MD, MSc, suggest trial data should address primary effectiveness end points, primary safety end points and key secondary end points.
The article was published in the midst of a 90-day public comment period on FDA draft guidance relating to this issue. In December 2011, the FDA released draft guidance, titled "Evaluation of Sex Differences in Medical Device Clinical Studies," focusing on underrepresentation of women in device clinical trials. The guidance recommends the following regarding achieving representative enrollment:
"Many clinical studies do not enroll proportions of women that reflect the underlying disease distribution in the affected population. This can be problematic because the ability to detect differences in response to treatment is markedly diminished if there is no or limited clinical experience with the product in the subgroup of interest. This has contributed to a substantial lack of available data regarding the risks and benefits of medical device use in women. FDA recommends that you strive to enroll representative proportions of women and men (i.e., consistent with disease prevalence) to improve the quality and consistency of available sex-specific data for your device."
The public comment period on the draft guidance began Dec. 19, 2011.
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