FDA Will Address Information Gap for Women in Medical Device Clinical Trials

June 23, 2014—In the US Food and Drug Administration’s (FDA) Voice blog, David Strauss, MD, PhD, advised that the agency will be taking steps this summer to address an “information gap” that contributes to the issue of a low number of women enrolling in some clinical trials for medical devices. Dr. Strauss is a medical officer with the FDA’s Center for Devices and Radiological Health (CDRH). 

First, the CDRH intends to finalize a guidance document on the evaluation of sex differences in medical device clinical studies that provides a clear framework for how to analyze and communicate data on women in medical device clinical trials. The draft guidance document was issued in December 2011.

Second, the FDA intends to release an Action Plan—mandated by Congress—that contains recommendations for improving the completeness and quality of analyses of data on women, as well as other populations, in summaries of product safety and effectiveness data and in labeling.

As Dr. Strauss noted, results from clinical trials often serve as the foundation for the CDRH’s decisions to approve the most important medical devices—those that carry the greatest risk to patients and have the potential to save or sustain life. The agency looks for potential gaps in that foundation that could be filled with more information or data. One of these information gaps is that not enough women are being enrolled in some clinical trials.

According to Dr. Strauss, underrepresentation of women (or minority or ethnic groups) results in a lack of information for these patients and their physicians regarding risks and benefits of some medical products. Certain differences between women and men, including anatomy and physiology, can lead to medical devices performing better or worse. The FDA is actively trying to learn more about how to optimize the safe and effective use of medical devices in women.

Additionally, in a recent CDRH initiative that was supported by the FDA’s Office of Women’s Health, Dr. Strauss and colleagues performed an analysis of data from multiple clinical trials that were conducted in support of cardiac resynchronization therapy (CRT). This was the FDA’s first individual patient data analysis involving medical devices from multiple companies.
 
On June 23, the study was published by Robbert Zusterzeel, MD, et al online ahead of print in the Journal of the American Medical Association (JAMA): Internal Medicine.

The study investigators found that only 22% of the patients in the clinical trials were women. They combined individual patient data from the multiple trials to increase the number of women in the analysis. They found that women benefit from CRT significantly more than men do. Patients of both sexes with a left bundle branch block (LBBB) benefited most. However, women did so at a shorter QRS duration than men. In the patients with LBBB and shorter QRS duration, women had a 76% reduction in heart failure or death, but there was no significant benefit in men. With LBBB and a longer QRS duration, both women and men benefitted from CRT. 

C. Noel Bairey Merz, MD, and Vera Regitz-Zagrosek, MD, contributed invited commentary regarding this study. “The Case for Sex- and Gender-Specific Medicine” is also available online ahead of print in JAMA: Internal Medicine. 

Dr. Strauss stated that this study illustrates that combining individual patient data from multiple clinical trials is an additional research tool that can help answer questions about patient groups that are underrepresented in clinical trials and help the FDA and CDRH strengthen the foundation for all medical devices on the market.