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On the Role of Randomized Clinical Trials in Medicine

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The placebo-controlled, double-blind, randomized clinical trial (RCT) holds unique advantages for evaluating medical technologies, and figures prominently in clinical drug investigations. However, medicine, like other social sectors, has experienced a movement toward evidence-based practice and policy decision-making that involves the evaluation of complex non-pharmacological interventions that frequently challenge the use of the RCT. Even with pharmaceuticals used in clinical practice, the application of RCTs has its limitations and challenges. This paper argues that both the modality of therapy (drugs, devices, and procedures) and the stage of technological evolution are important determinants of an optimal evaluative design. The practicality of conducting an RCT is inversely proportional to the complexity of the healthcare intervention. Iterative modifications of medical devices, provider-specific practices, and an evolving clinical knowledge-base are just some of the problems plaguing technology assessments. Lessons learned on the role of randomized versus observational study designs may prove valuable for other social sectors.

Keywords: Clinical practice; Devices; Drugs; Education; Randomized clinical trial

Document Type: Research Article


Affiliations: 1: International Center for Health Outcomes and Innovation Research, Columbia University, New York, USA 2: School of International and Public Affairs, Columbia University New York, USA 3: Department of Economics, Stanford University, New York, USA

Publication date: July 1, 2007

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