FDA Issues Draft Guidance for Increasing Women Representation in Medical Device Clinical Trials
The FDA has issued a draft guidance that aims at increasing the representation of women in medical device clinical trials. Aimed at medical device manufacturers and developers, the guidance outlines agency recommendations for designing and conducting device clinical studies that may enhance the enrollment of women in such studies, if appropriate.
Why a specific guidance aimed at increasing women in medical device clinical trials?
The FDA states that there was a need for such a guidance document as certain medical products may elicit different responses in women than in men. The reasons for this may include the basic differences in men and women, such as genetics, hormones, body size, diet, and socio-cultural issues.
There’s also a safety issue. Certain variables associated with women, such as size or certain illnesses, may be responsible for certain differences between men and women in the safety and effectiveness of medical devices.
A 2001 report by the U.S. Government Accountability Office (GAO) on FDA-reviewed drug studies found that while women represented 52 percent of study enrollees, 30 percent of study documents did not report outcomes by sex and nearly 40 percent did not report enrollment demographics. A 2009 study of cardiovascular device pre-market applications showed that pivotal studies that reported sex enrolled an average of 33.9 percent women.
What does the draft guidance address?
The FDA’s draft guidance addresses study and evaluation of sex differences, data analysis and reporting in both pre- and post-market device clinical studies. Also included in the guidance are recommendations for statistical analyses of sex differences and how to report sex-specific information in summaries and labeling for approved devices.
Scope
This guidance is intended for medical devices that require clinical information in support of a marketing submission, whether a premarket notification (510(k)), premarket approval (PMA) application or humanitarian device exemption (HDE) application.
The guidance does not apply to medical devices aimed at a specific sex such as OB-GYN or urology devices.
Summary of Guidance Recommendations
Consideration of Potential Sex Differences
Manufacturers should include the following background information about the disease or condition which the device treats in study and submission documents:
- Sex-specific prevalence;
- Sex-specific diagnosis and treatment patterns;
- Identification of proportions of women included in past studies for the target indication;
- Identification of any known clinically significant sex differences in outcomes related to either safety or effectiveness
The above information should be included in the following documents:
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New or Ongoing Studies (IDE study design/early enrollment stage)
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Completed Studies (marketing application stage)
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Postmarket Studies (PAS or 522 PS stage)
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Information should be included in the:
- Interrim reports
- Results section of the final report
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How can medical device manufacturers increase enrollment of women in clinical studies?
The FDA draft guidance provides the following recommendations for various studies that can increase the enrollment of women:
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New or Ongoing Studies (IDE study design/early enrollment stage)
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Completed Studies (marketing application stage)
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Postmarket Studies (PAS or 522 PS stage)
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Need a better understanding of FDA regulations on clinical trials? Then attend any of the following ComplianceOnline webinars:
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Recommendations for Sex-Specific Statistical Analysis
After overall effectiveness and safety have been investigated, the influence of sex on primary endpoints for both safety and effectiveness (and in some cases for important secondary endpoints as well) should be assessed. The FDA recommends the following methods:
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Subgroup Analysis
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Data should be examined for clinically meaningful sex differences in each of the following:
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Testing for Interaction or Heterogeneity
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Recommendations for Reporting Sex-Specific Information in Summaries and Labeling
Information about the sex-specific effects of the device being studied should be reported in the following manner for different kinds of studies:
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New or Ongoing Studies (IDE study design/early enrollment stage)
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Information to be included in annual progress reports
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Completed Studies (marketing application stage)
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- Information should be included in marketing application in sections containing results of clinical investigations
- Summary of information should also be included in the draft PMA Summary of Safety and Effectiveness or 510(k) Summary.
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Postmarket Studies (PAS or 522 PS stage)
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Information should be reported in:
- Interrim reports
- Results section of final report
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The results of sex-specific outcomes analyses should be presented in the labeling, regardless of whether the analyses are pre-specified or post hoc.
Additional Resources
Compliance Trainings
Use of Electronic Health Record Data (EHR) in FDA regulated clinical investigations
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