The FDA issued a draft guidance on the study and evaluation of gender differences in medical device clinical studies. The guidance is issued with hopes to increase the number of female subjects enrolled in clinical trials.
Why is the inclusion of women important in such cases? Certain medical devices could elicit different responses depending on gender, according to the federal watchdog agency. Basic differences such as genetics, hormones, body size, diet and socio-cultural issues may play a role in the efficacy of medical devices in patients, the FDA said. This was further elaborated on in a MassDevice article which states that “A 2009 study of cardiovascular med-tech premarket approval applications showed that only 1 in 3 patients enrolled in pivotal trials were women. A 2001 report by the U.S. Government Accountability Office found that nearly 40% of studies didn't report enrollment demographics.”
Studies have shown that women may be less likely to enroll in clinical studies. According to a 2008 FDA Workshop, some suspicions of why women are under represented in clinical studies include:
- Fear of fetal consequences if the woman becomes pregnant.
- Lack of understanding about differences in disease etiology and pathophysiology may lead to under-diagnosis and under-referral of women.
- Avoidance of female patients by investigators and sponsors due to the perception that it takes more time and money to recruit them.
- Inclusion/exclusion criteria that may not be necessary to define the study population may unintentionally exclude women.
- Family responsibilities which limit ability for time commitment to study follow-up.
The draft guidance also suggests approaches to enhance the enrollment of women by considering the following approaches:
- Target investigational sites where recruitment of women can be more easily facilitated (e.g., women’s clinics).
- If women are likely to benefit from your device but may not meet certain study enrollment criteria, consider parallel cohorts for collecting data on device use in women.
- Plan focused efforts to enroll women under a continued access study.
- Include provisions to ensure certain minimum enrollment for women (e.g., maintain open enrollment for women until pre-specified proportion is reached).
- Consider flexibility in follow-up visit scheduling with provision of child care or elder care services during appointments.
It is critical that the group of patients enrolled in a study represent the population that may receive the device once it is on the market. How do you think the FDA’s draft guidance, Evaluation of Sex Differences in Medical device Clinical Studies, will effect our industry? Please share your thoughts with us!
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