Inclusion of women in medical device studies critical!

Most people know that human clinical trials are critical to prove safety and efficacy in new medications.   This is also true for medical devices yet a recent study indicated that only 14% of device studies included sex as a key outcome measure, and only 4% included a subgroup analysis for female participants.    The differences in anatomy and physiology, as well as other factors in men and women,  can lead to devices working less effectively and safely.

The FDA’s Office of Women’s Health  recently supported a study of clinical trials conducted on cardiac resynchronization therapy (CRT), a pacemaker therapy for patients with heart failure.  Only 22% of the clinical trial participants were women.   By combining multiple studies and mining the multi-study data, the FDA Center for Devices and Radiological Health (CDRH) found that women benefited more than men from CRT.

This particular study demonstrates that we need adequate samples of men and women in studies early in the research process.   The good news is the FDA is taking two steps to insure more sex inclusion is built int0 future studies:

  • The FDA will finalized a guidance document that provides a clear framework for the inclusion of women in device studies
  • Mandated by Congress, the FDA will release an Action Plan, that will further address the analysis of data on women and product and safety data in labeling for drugs and devices.

How can you help??  Ask you doctor if there are clinical studies looking for subjects or contact your local medical school.    If you live in Illinois, you can join the Illinois Women’s Health Registry  a gateway to clinical trials in Illinois.

Source:  FDA VOICE, June 23, 2014