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Center for Devices and Radiological Health, Clinical trial, FDA, Food & Drug Administration, Government Accountability Office, Jeffrey Shuren, Medical device, Medicine
FDA seeks to include more women in medical device trials.
FDA seeks to include more women in medical device trials
The FDA has released draft guidance aimed at increasing the number of women participating in clinical trials for medical devices.
Clinical trials tend to under-represent women, the agency explained in a Dec. 16 statement, which added, “This represents a shortcoming in typical study design because medical products may affect women differently than men due to genetics, hormones, body size, diet, social and cultural factors, and types of illness.”
The release pointed to a 2001 report by the U.S. Government Accountability Office (GAO) on FDA-reviewed drug studies showing that, while women represented 52 percent of study enrollees, 30 percent of study documents did not report outcomes by sex and nearly 40 percent did not report enrollment demographics.
The draft guidance addresses study and evaluation of sex differences, data analysis and reporting in studies performed both before and after FDA approval. It also covers issues around statistical analyses of sex differences and how to report sex-specific information in summaries, along with labeling for approved devices.
“The FDA recommends that investigators and manufacturers strive to enroll representative proportions of both women and men in their device studies,” said Jeffrey Shuren, MD, director of the FDA’s Center for Devices and Radiological Health. “Our draft guidance outlines what we recommend for obtaining and improving the quality and consistency of sex-specific data on devices.”
The FDA is seeking input during a 90-day comment period beginning Dec. 19. The draft guidance is posted here.
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This is great news. Does this actually mean the medical device world will be telling people that they are participating in studies, instead of the lab rat approach.
Even with my new hip, there is no real hard core data as to good nor adverities regarding the product, other than a lot of surgeons are now using my device.
Although I never received notification,as with thousands of other people we basically are the lab rats.
The good thing is I now understand the medical device world and how it dictates the rules, the bad thing I never see adversities in using certain devices. Example there never has,to my knowledge been any warning that ” metal on metal ” hips my be hazardous to your health. See your doctor if you are experiencing a problem with your metal on metal implant. More importantly make sure you are completely satisfied with any questions you ask your doctor as to a problem, if you aren’t satisfied see another doctor.
Know you are not alone, going through surgery, rehab, and all the ups and downs that are connected.
Yes, there are fortunately more success stories with hip procedures than failures, however, the medical device manufacturers and their metal on metal hips have hurt too many people and for this they must be held accountable, after all we are human beings.
Respectfully
Howard Sadwin
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