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. 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, according to FDA.
In December of 2011, FDA issued a draft guidance on the study and evaluation of gender differences in medical device clinical studies. The guidance has specific objectives to:
- Provide recommendations for study design and conduct to encourage enrollment of women in proportions that are representative of the demographics of disease distribution;
- Outline recommended statistical analyses of study data for sex differences, and to identify sex-specific questions for further study;
- Encourage the consideration of sex and associated covariates (e.g., body size, plaque morphology, etc.) during the study design stage; and
- Specify CDRH’s expectations for reporting sex-specific information in summaries and labeling for approved devices
Now FDA is posting a notice of a public workshop in June 2013. According to the post, The CDRH HoW (Health of Women) program seeks to bring together clinicians, researchers, academia, government agencies, industry, and patient / advocacy groups to educate, enlist, and explore the unique issues related to the performance of medical devices in women.
Participation in the HoW workshop is free and will focus will be device - and disease-specific, patient-centered and action-oriented. The overall mission of the HoW program is to:
- Improve the availability, consistency and communication of sex-specific information for the safe and effective use of medical devices in women;
- Address identified gaps and unmet needs through targeted resources; and
- Foster the development of innovative strategies, technology and clinical study paradigms
How do you think the HoW program will impact the participation of women in clinical research trials? Do you think there is a better way to recruit and retain women in medical device studies? Share your thoughts below!
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