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Compliance In Focus
Posted by Stephani Hulec on Fri, Jan 31, 2014

Women in Post-Approval Medical Device Studies

Should women be treated differently than men in regards to medical device trials?  According toWomen in Post Approval Medical Device Studies this recent medical news statement, the FDA feels that more should be done to ensure that an adequate number of women are enrolled in post-approval studies, to analyze any potential differences caused by gender.  The Journal of Women's Health recently published an article entitled Enrollment and Monitoring of Women in Post-Approval Studies for Medical Devices Mandated by the FDA.

The goal of this research was to determine the participation rate of women in post-approval medical device studies overseen by the FDA.  The study examined 89 trials, and saw that most (93%) did evaluate sex in their enrollment parameters.  However, less than half of these trials (43%) had gender data analyzed when reported.  The article notes the importance of ensuring that any potential sex-related differences in device safety and effectiveness is evaluated; because of this, studies should make a point to enroll an appropriate number of women in correlation to the number of men enrolled.

As discussed in the article, there is the possibility that differences in internal factors between men and women (such as genetics, physiology, hormonal fluctuations, etc.) may cause distinct responses, depending on whether the device is used on or implanted in one sex versus the other.

There have been other studies, as cited in this article, where gender may have played a role- for example here, in the safety and effectiveness of a device; and here, in the condition the device was treating.  Although it is documented across a variety of fields that gender may have a significant effect on the device being evaluated in a clinical trial, the overall conclusion in this study was that “data on sex was not routinely assessed in FDA reviews”.  In fact, the article states that “based on these findings, the FDA has since implemented new procedures to ensure that participation by sex is evaluated in PAS [post-approval study] reviews”.

Do you agree that gender differences are a valid concept that should be evaluated for post-market medical device studies?

Photo Credit: Kheel Center, Cornell University

The History of Clinical Research Timeline

Topics: Women, Post Approval Studies, Medical Studies, FDA


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