Value-Based Hypothesis Testing for Cardiac Device Clinical Trials: A Pathway for Accelerated Reimbursement Decisions.
From Cardiology Division, Department of Medicine, Beth Israel Deaconess Medical Center, Harvard Clinical Research Institute, Harvard Medical School, Boston, MA. dcutlip@bidmc.harvard.edu.
Donald E
DE
Cutlip
From Cardiology Division, Department of Medicine, Beth Israel Deaconess Medical Center, Harvard Clinical Research Institute, Harvard Medical School, Boston, MA.
Daniel B
DB
Kramer
D002986:Clinical Trials as Topic; D003362:Cost-Benefit Analysis; D018795:Device Approval; D004864:Equipment and Supplies; D006331:Heart Diseases / Q000191:economics / Q000453:epidemiology* / Q000601:surgery; D019918:Heart Valve Prosthesis Implantation; D006801:Humans; D006278:Medicare; D062645:Percutaneous Coronary Intervention; D058996:Quality Improvement; D012051:Reimbursement Mechanisms; D012107:Research Design; D016896:Treatment Outcome; D014481:United States
Centers for Medicare and Medicaid Services (US); United States Food and Drug Administration; clinical trial; healthcare costs