title: Strategies for postmarketing surveillance of drugs and devices in patients with ESRD undergoing dialysis.
abstract: The lack of evidence on the effectiveness and safety of interventions in chronic dialysis patients has been a subject of continuing criticism. New technologies are often introduced into the market without having specifically studied or even included patients with advanced kidney disease. Therefore, the need to generate valid effectiveness and safety data in this vulnerable subpopulation is of utmost importance. The US Food and Drug Administration has recently placed an increased focus on safety surveillance, and sponsors must now meet this additional postmarketing commitment. In patients with ESRD, the unique data collection environment in the United States allows for creative and efficient study designs to meet the needs of patients, providers, and sponsors. The purpose of this manuscript is to review the methodological and practical aspects of the different options for postmarketing study design in this field, with critical appraisal of their advantages and disadvantages.
authors: Harvard Clinical Research Institute, Boston, Massachusetts;, †Division of Cardiology, Massachusetts General Hospital, Boston, Massachusetts;, ‡Cardiology Division, Department of Internal Medicine, Hennepin County Medical Center, University of Minnesota, Minneapolis, Minnesota;, §Division of Nephrology, Stanford University School of Medicine, Palo Alto, California;, ‖Duke Clinical Research Institute, Duke University School of Medicine, Durham, North Carolina, ¶Renal Division and Clinical Biometrics, Brigham and Women Hospital, Boston, Massachusetts.
authors: Moshe
authors: M
authors: Vardi
authors: Robert W
authors: RW
authors: Yeh
authors: Charles A
authors: CA
authors: Herzog
authors: Wolfgang C
authors: WC
authors: Winkelmayer
authors: Soko
authors: S
authors: Setoguchi
authors: David M
authors: DM
authors: Charytan
mesh_terms: D004867:Equipment Design; D006801:Humans; D007676:Kidney Failure, Chronic / Q000628:therapy*; D061214:Patient Safety; D011358:Product Surveillance, Postmarketing / Q000379:methods*; D006435:Renal Dialysis / Q000009:adverse effects / Q000295:instrumentation; D012107:Research Design; D018570:Risk Assessment; D012307:Risk Factors; D013997:Time Factors; D016896:Treatment Outcome; D064804:Urological Agents / Q000009:adverse effects / Q000627:therapeutic use*
chemical_list: D064804:Urological Agents
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