The FDA issued a draft guidance today designed to increase the number of female subjects enrolled in med-tech clinical trials.
Certain medical devices could elicit different responses depending on gender, according to the federal watchdog agency. Basic differences such as genetics, hormones, body size, diet and socio-cultural issues may play a role in the efficacy of medical devices in patients, the FDA said.
A 2009 study of cardiovascular med-tech premarket approval applications showed that only 1 in 3 patients enrolled in pivotal trials were women. A 2001 report by the U.S. Government Accountability Office found that nearly 40% of studies didn’t report enrollment demographics.
"The FDA recommends that investigators and manufacturers strive to enroll representative proportions of both women and men in their device studies," Dr. Jeffrey Shuren, director of the FDA’s Center for Devices & Radiological Health, said in prepared remarks. "Our draft guidance outlines what we recommend for obtaining and improving the quality and consistency of sex-specific data on devices."
The guidance would address gender issues in both pre and post-market device clinical studies. Devices intended for single-sex use would not be required to address potential gender efficacy issues under the FDA’s guidance.
Earlier this month, the federal watchdog agency issued a long-awaited draft guidance on an approval pathway for "artificial pancreas" devices.
The guidance centers on a three-phase approach to clinical trials for getting devices into an outpatient settings as quickly as possible, while providing some wriggle room on how to get there. Since no device has yet gone through the regulatory process, the guidance leaves the door open for developers to study endpoints and design.
The agency said it hopes to spur progress by providing flexible guidance and a clear path from feasibility studies to an outpatient study for the devices, which combine a continuous glucose monitor and an insulin pump to provide automatic moderation of blood sugar levels.
Several organizations are already working on the devices, including Medtronic (NYSE:MDT) and the Mayo Clinic.
The FDA last month granted Medtronic’s MiniMed Paradigm system an investigational device exemption for the second phase of the Automation to Simulate Pancreatic Insulin Response trial, which will involve in-home study of its subjects (the trial’s first leg involved in-patient treatment).