title: Enrollment and monitoring of women in post-approval studies for medical devices mandated by the Food and Drug Administration.
abstract: BACKGROUND
  Disease presentation, prevalence, and treatment effects vary by sex, thus it is important to ensure adequate participation of both sexes in medical device post-approval studies (PAS).
  
  
  METHODS
  The goals of this study were to determine the participation rate of women in PAS mandated by the Food and Drug Administration (FDA) and if participation varied by clinical area. The study also evaluated the frequency in which enrollment by sex is reported by applicant reports and FDA reviews, as well as the frequency in which final study reports analyze whether outcomes differ by sex.
  
  
  RESULTS
  Of 89 studies with enrollment completed, data on sex of participants were available in 93% of submitted reports, while data on enrollment by sex was evaluated and noted in 43% of FDA review memos. Study participation varied by clinical area, with female participation ranging from 32% in cardiovascular PAS to 90% in PAS for reconstructive devices. Of 53 completed studies, data on enrollment by sex was provided in 49 of the final reports. Of these 14% included a multivariate analysis that included sex as a covariate and 4% included a subgroup analysis for female participants.
  
  
  CONCLUSIONS
  Data on sex was not routinely assessed in FDA reviews. Based on these findings, FDA implemented new procedures to ensure participation by sex is evaluated in PAS reviews. FDA will continue working with applicants to develop PAS that enroll and retain proportions of women consistent with the sex-specific prevalence for the disease or condition the device is used to treat.
authors.affiliation: Food and Drug Administration , Center for Devices and Radiologic Health, Silver Spring, Maryland.
authors.forename: Ellen
authors.initials: E
authors.lastname: Pinnow
authors.forename: Naomi
authors.initials: N
authors.lastname: Herz
authors.forename: Nilsa
authors.initials: N
authors.lastname: Loyo-Berrios
authors.forename: Michelle
authors.initials: M
authors.lastname: Tarver
mesh_terms: D000328:Adult; D018795:Device Approval; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D010358:Patient Participation / Q000706:statistics & numerical data*; D018579:Patient Selection; D011358:Product Surveillance, Postmarketing; D012189:Retrospective Studies; D015983:Selection Bias; D012737:Sex Factors; D014481:United States; D014486:United States Food and Drug Administration