This article is more than 5 years old. Information may no longer be current.
New FDA guidance encourages enrollment of women in device trials
Click Here to Manage Email Alerts
The FDA has released a new guidance document that encourages the enrollment of more women in clinical trials of medical devices.
“Historically, women have been under-represented in or excluded from many clinical studies,” the report states. “This has led to a lack of information available for women and their physicians regarding the risks and benefits of many medical treatments and diagnostic procedures.”
During a webinar held on Aug. 25, Jismi Johnson, biomedical engineer and lead medical device reviewer, said the new guidance encourages the appropriate enrollment of both sexes in clinical trials, as well as sex-specific data analysis both during and after the trial.
The guidance also recommends that the prevalence of certain medical conditions among men and women should be taken into consideration when determining how many women to enroll.
“We acknowledge that it may not be applicable for all devices, such as Ob/Gyn and urology devices intended for a single sex,” Johnson said.
A 2013 report by the FDA showed that participation rates of women “varied widely” by device type, according to slides presented by Johnson. Cardiac resynchronization therapy defibrillators (CRT-Ds) were named as an example of one such device. Johnson reported that, although both sexes experienced benefit from CRT-Ds, the rate was higher among women than men (77% vs. 42%). The purpose of the new guidance is to develop a better understanding of how men and women respond to devices, providing physicians with more data when making treatment decisions. If analysis of the trial data reveals no significant differences between men and women, no further analysis is expected when reporting to the FDA, according to Johnson.
When asked how transgendered participants should be classified, Johnson said that study sponsors should discuss the circumstances with the FDA to handle on “a case-by-case” basis, and that more consideration and discussion on the topic would follow.
Johnson also said that study sponsors are encouraged to review previous studies and analyze the data according to sex-specific subgroups.