Gender Bias in Studies for FDA Premarket Approval of Cardiovascular Devices
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Women have been under-represented in clinical trials for several decades and a large amount of medical knowledge is based on data in men which are extrapolated to women. Over the past few decades, attempts have been made to increase our understanding of risks and benefits of drugs and devices in women, but the latter have been under-studied. The premarket approval process is used by the FDA to evaluate the safety and effectiveness of high-risk medical devices. The safety and effectiveness of a substantial minority of these devices has been shown to differ by sex. However, pivotal studies of these devices that lead to FDA approval often do not include adequate numbers of women nor do most stratify outcomes by sex. Numerous attempts and initiatives to increase availability of sex-specific data have improved this evidence gap modestly, but additional policy changes are necessary to optimize safety and effectiveness evaluation in women.
KeywordsFDA Device regulation Women
Compliance with Ethics Guidelines
Conflict of Interest
Sanket Dhruva declares no conflicts of interest. Esme Cullen declares no conflicts of interest. Rita Redberg declares no conflicts of interest.
Dr. Redberg is a current member of the FDA Circulatory System Devices Panel.
Human and Animal Rights and Informed Consent
This article does not contain any studies with human or animal subjects performed by the author.
Papers of particular interest, published recently, have been highlighted as: •• Of major importance
- 3.United States General Accounting Office. National Institutes of Health: problems in implementing policy on women in study populations. http://archive.gao.gov/d48t13/141859.pdf. Accessed 2 Apr 2014.
- 4.Department of Health and Human Services. Office of Device Evaluation annual report for fiscal year 1994. Washington DC: US Department of Health and Human Services; 1994. p 26.Google Scholar
- 5.Food and Drug Administration. Medical Devices: Premarket Approval. Silver Spring: Food and Drug Administration; 2012. http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/HowtoMarketYourDevice/PremarketSubmissions/PremarketApprovalPMA/default.htm. Accessed 2 Apr 2014.
- 9.Dhruva SS, Bero LA, Redberg RF. Strength of study evidence examined by the FDA in premarket approval of cardiovascular devices. JAMA. 2009;2679–85.Google Scholar
- 10.••Dhruva SS, Bero LA, Redberg RF. Gender bias in studies for Food and Drug Administration premarket approval of cardiovascular devices. Circ Cardiovasc Qual Outcomes. 2011;4:165–71. This study describes the current state of available data for cardiovascular devices in women at the time of approval.PubMedCrossRefGoogle Scholar
- 11.Food and Drug Administration. Summary of safety and effectiveness. PMA 000009: Phylax AV ICD with Programmer Software (I-GAV.2.U). Food and Drug Administration, Center for Devices and Radiological Health, Office of Device Evaluation; 2000. http://www.accessdata.fda.gov/cdrh_docs/pdf/P000009b.pdf. Accessed 2 Apr 2014.
- 14.Ghanbari H, Dalloul G, Hasan R, Daccarett M, Saba S, Machado C. Effectiveness of implantable cardioverter-defibrillators for the primary prevention of sudden cardiac death in women with advanced heart failure: a meta-analysis of randomized controlled trials. Arch Intern Med. 2009;169:1500–6.PubMedCrossRefGoogle Scholar
- 17.Arshad A, Moss AJ, Foster E, Padeletti L, Barsheshet A, Goldenberg I, et al. Cardiac resynchronization therapy is more effective in women than in men: the MADIT-CRT (Multicenter Automatic Defibrillator Implantation Trial with Cardiac Resynchronization Therapy) Trial. J Am Coll Cardiol. 2011;57:813–20.PubMedCrossRefGoogle Scholar
- 22.Institute of Medicine. Women's health research: progress, pitfalls, and promise. Washington, DC: National Academies Press; 2010.Google Scholar
- 23.••Food and Drug Administration. Draft guidance for industry and Food and Drug Administration staff – evaluation of sex differences in medical device clinical studies. Silver Spring: Food and Drug Administration; 2011. This is the FDA’s draft guidance and provides guidelines for effectively evaluating medical devices in women.Google Scholar