FDA Seeks to Get More Women Into Trials of Medical
FRIDAY, Dec. 16 (HealthDay News) -- Draft recommendations meant
to increase the number of women in clinical trials for medical
devices were released Friday by the U.S. Food and Drug
Genetics, hormones, body size, diet, social and cultural
factors, and types of illness may cause women to respond
differently to certain medical products and devices than men,
according to the FDA.
But, women are typically underrepresented in clinical trials.
For example, a 2009 study of applications for approval of
cardiovascular devices found that average female enrollment in
important trials that included gender information was only 33.9
The FDA's draft guidance -- intended for medical device
developers and manufacturers -- includes recommendations for
designing and conducting medical device clinical trials in a way
that may increase the enrollment of women, said Dr. Jeffrey Shuren,
director of the FDA's Center for Devices and Radiological
"The FDA recommends that investigators and manufacturers strive to enroll representative proportions of both women and men in their device studies," he said in an FDA news release. "Our draft guidance outlines what we recommend for obtaining and improving the quality and consistency of sex-specific data on devices."
The document covers study and evaluation of sex differences,
data analysis, and reporting in clinical studies conducted both
before and after market approval. It also deals with statistical
analyses of sex differences, how to report sex-specific information
in summaries, and sex-specific labeling for approved devices.
There is a 90-day public comment period on the draft
Here's where you can find the
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