title: Improving the Safety and Effectiveness of Medical Device Therapy in Women.
abstract: When not enough women are included in many clinical trials, an information gap on medical device safety and effectiveness exists, which can make it difficult to detect sex-specific results. In this article we discuss potential reasons for the underrepresentation of women and the regulatory research conducted by the U.S. Food and Drug Administration (FDA) used in supporting regulatory decisions. We demonstrate that important differences in cardiovascular device performance between women and men exist. Furthermore, concrete steps are outlined on the possible ways these sex-specific results can be detected and how a recent FDA Action Plan and Guidance Document aim at encouraging female participation in clinical trials and the appropriate analysis thereof.
authors.affiliation: U.S. Food and Drug Administration , Silver Spring, Maryland.
authors.forename: Robbert
authors.initials: R
authors.lastname: Zusterzeel
authors.affiliation: U.S. Food and Drug Administration , Silver Spring, Maryland.
authors.forename: Kathryn M
authors.initials: KM
authors.lastname: O'Callaghan
authors.affiliation: U.S. Food and Drug Administration , Silver Spring, Maryland.
authors.forename: Daniel A
authors.initials: DA
authors.lastname: Caños
authors.affiliation: U.S. Food and Drug Administration , Silver Spring, Maryland.
authors.forename: William E
authors.initials: WE
authors.lastname: Sanders
authors.affiliation: U.S. Food and Drug Administration , Silver Spring, Maryland.
authors.forename: Danica
authors.initials: D
authors.lastname: Marinac-Dabic
authors.affiliation: U.S. Food and Drug Administration , Silver Spring, Maryland.
authors.forename: David G
authors.initials: DG
authors.lastname: Strauss
mesh_terms: D058406:Cardiac Resynchronization Therapy; D002986:Clinical Trials as Topic; D057186:Comparative Effectiveness Research; D003257:Consumer Product Safety; D018795:Device Approval; D004864:Equipment and Supplies; D005260:Female; D006333:Heart Failure / Q000628:therapy*; D006805:Human Experimentation; D006801:Humans; D018579:Patient Selection; D014481:United States; D014486:United States Food and Drug Administration; D016387:Women's Health