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- Title
Improving the Safety and Effectiveness of Medical Device Therapy in Women.
- Authors
Zusterzeel, Robbert; O'Callaghan, Kathryn M.; Caños, Daniel A.; Sanders, William E.; Marinac-Dabic, Danica; Strauss, David G.
- 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.
- Subjects
HEART failure treatment; CARDIAC pacing; CLINICAL medicine research; DECISION making; PATIENT safety; SEX distribution; UNITED States. Food &; Drug Administration; WOMEN'S health; PATIENT participation; GOVERNMENT regulation; HUMAN research subjects; PATIENT selection; EQUIPMENT &; supplies
- Publication
Journal of Women's Health (15409996), 2016, Vol 25, Issue 5, p428
- ISSN
1540-9996
- Publication type
Article
- DOI
10.1089/jwh.2015.5605