Strauss highlights the importance of clinical trails and that at FDA’s Centre for Devices and Radiological Health (CDRH), for example, results from clinical trials often serve as the foundation for the FDA’s decisions to approve medical device, some of which, eg, implantable heart devices, carry a great risk to patients and have the potential to save or sustain life.
Strauss says that the underrepresentation of women (or minority or ethnic groups) is significant and ultimately results in a lack of information for these patients and medical professionals regarding risks and benefits of some medical products. Certain differences between women and men, he says such as those relating to anatomy and physiology, can lead to medical devices performing better or worse.
The FDA is currently keen to increase its knowledge on how to optimise the safe and effective use of medical devices in women.
“With support from FDA’s Office of Women’s Health, CDRH recently performed an analysis of data from multiple clinical trials conducted in support of cardiac resynchronisation therapy (CRT), a pacemaker therapy for patients with heart failure. Only 22% of the patients in the clinical trials were women. We combined individual patient data from multiple clinical trials to increase the number of women in the analysis,” writes Strauss.
“We found that women benefit from CRT significantly more than men do. Patients of both sexes with a left bundle branch block (LBBB), an electrical conduction disorder in the heart, benefited most. However, women 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. With LBBB and a longer QRS duration, both women and men benefitted from CRT,” he added.
To address this information gap, the FDA is implementing two new measures over coming months.
One of these is that CDRH intends to finalise guidance giving a clear framework on how to analyse and communicate data on women in medical device clinical trials.
Secondly, the FDA plans to release an Action Plan which will offer 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.”