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Compliance In Focus
Posted by John Lehmann on Wed, Jul 24, 2013

“HoW” the FDA is Looking at Women and Medical Devices

Cardiovascular disease is the number one killer of women over 25 in the United States.“HoW” the FDA is Looking at Women and Medical Devices Females account for 50.9% of the total US population and 63.1% of participants in National Institute of Health funded clinical research trials. However, female representation is lowest in studies for heart failure (29%), coronary artery disease (25%) and hyperlipidemia (28%) while females account for 51% of all individuals with heart failure, 46% for coronary heart disease, and 49% of those diagnosed with hyperlipidemia. Enrollment of woman in cardiovascular trials has increased over time, but remains low relative to their overall representation of the disease population as noted in a 2010 study titled “Representation of women in randomized clinical trials of cardiovascular disease prevention.” 

In June, the Center for Device and Radiologic Health (CDRH) launched the “Health of Women” or “HoW” Program, aimed at learning how to improve the health of women by exploring some of the unique issues related to medical device performance in women.  The mission, as noted on the FDA website, is to improve the health of women by:

  • Improving availability, consistency, and communication of medical device use in women
  • Using targeted resources to address identified gaps and unmet needs of women
  • Fostering the development of innovative strategies, technologies, and clinical study paradigms

Additionally, the program was organized to address issues related to recruitment and retention of women in clinical trials. This comes after the 2011 draft guidance, Evaluation of Sex Differences in Medical Device and Clinical Studies, which is intended to improve the quality of data in medical device trials in both sexes by ensuring appropriate representation and stratification by  sex differences. The FDA recommended that sponsors strive to enroll proportions of males and females that are representative of true disease prevalence to improve data quality for medical device trials.

The “HoW” program focuses on musculoskeletal and cardiovascular disease with topics related to osteoporosis, total joint arthroplasty, metal-on-metal hip implant fracture rates, , endovascular treatments for abdominal aortic aneurysms, and cardiac resynchronization.

Little information is known at this time about the initiatives and outcomes resulting from this meeting held on June 24-25, 2013.

If this program continues at the CDRH, what other disease areas would you like to see more focus for women? What do you think are the reasons that more women aren’t participating in clinical trials? Please share your thoughts here.

Photo Credit: lanier67

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Topics: Medical Devices, Women, "HoW", Cardiovascular Disease


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