News Feature | June 30, 2014

FDA Takes Initiative To Fill Gender Data Gaps In Device Clinical Trials

By Nick Otto

FDA EHR Pilot Program

In its continued effort for more thorough analysis on the efficacy of medical devices in subpopulations, the FDA is looking to find ways at filling the gender gaps currently seen in clinical trial participation.

The agency recently announced its vested interest in getting more female participants in device trials, noting that the sub-par representation of women leaves lingering questions about the true risks and benefits devices provide, due to the anatomical and physiological differences between men and women.

For example, the agency says women benefit from cardiac resynchronization therapy (CRT) at a higher rate than men.

The FDA’s Center for Devices and Radiological Health (CDRH) partnered with the Office of Women’s health to analyze data from multiple cardiac resynchronization therapy (CRT) clinical trials, in which only 22% of patients were women.

Both genders with a left bundle branch block (LBBB), an electrical conduction disorder in the heart, showed the most benefit in the trials. Women, however, did so at a shorter QRS duration – time to complete electrical activation of the heart – than men. “In the patients with LBBB and shorter QRS duration, women had a 76 percent reduction in heart failure or death, while there was no significant benefit in men,” David Strauss, a CDRH medical officer, said in a recent blog post. This demonstrates an obvious higher efficacy in one gender over the other.

Further details of this specific study can be found in the Journal of American Medical Association: Internal Medicine (JAMA).

While these findings show women are more likely to benefit from CRT-defibrillator treatment, the study also shows the “potential public health and regulatory science value of combining data from multiple clinical trials submitted to the FDA,” the JAMA article states.

Strauss notes in the coming summer months, the FDA is planning a two-fold initiative to address the current gender “information gap.”

The first is finalizing an earlier draft guidance outlining the agency’s recommendations for designing and conducting device clinical studies that may enhance the enrollment of women.

The second is to produce an action plan aimed at tackling Congressional recommendations to improve the quality and analysis of data on all specific populations, including women, in product safety and efficacy data.

The “FDA has been working hard on many of these issues for over 30 years,” FDA Commissioner Margaret Hamburg said at a public hearing to discuss challenges in collecting subgroup clinical data. “Our recognition of the importance of studying specific subpopulations was reflected in the 1980s, when we first issued guidance about the importance of studying the effects of drugs in elderly patients.”