December 9, 2009

Women Underrepresented in Medical Device Testing Trials

By Kelley Luckstein

While it is controversial, many within the medical community believe women are underrepresented in national clinical trials for medical devices, leading to a lack of information about the differences between women’s and men’s health…


The roots of this underrepresentation come from a 1977 recommendation by the FDA to exclude women of “reproductive potential” from the early phases of clinical trials. According to Ameeta Parekh, the Research and Development Program Director in the FDA’s Office of Women’s Health, this resulted in the broad exclusion of women in most trial stages…


Jamie Roberts, Protocol Development Coordinator at Mayo Clinic’s Cancer Center, said the FDA’s recommendation really only documented a practice that had been going on long before 1977…


“There is always a chance that we might be missing something that has a huge mortality benefit if we never tested it,” said Carolyn Landolfo, Cardiac Specialist at Mayo  Clinic.


Skirt! by Sara Conrad, 12/7/09

Tags: Cancer, Cardiology, medical device testing, reproductive potential, Research

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