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January 1, 1997

Should Clinical Trials With Concurrent Economic Analyses Be Blinded?

Author Affiliations

From the Centre for Health Economics (Mr Freemantle and Dr Drummond) and the Department of Health Sciences and Clinical Evaluation (Mr Freemantle), University of York, York, England.

JAMA. 1997;277(1):63-64. doi:10.1001/jama.1997.03540250071034

ECONOMIC ANALYSES are increasingly conducted alongside clinical trials, as the funders of research recognize that they require estimates of both the costs and benefits of health care interventions. In fact, many commissioning organizations will fund clinical trials only if they are designed to provide estimates of cost-effectiveness, and economic analyses are already being used to inform decisions on the reimbursement of pharmaceuticals in some health care systems.1 The addition of economic data collection and analysis to clinical trials raises a number of important methodological issues,2 including whether those clinical trials incorporating an economic analysis should be blinded.

Rationale for Blinding in Clinical Trials  Blinding physicians and patients to treatment allocation in clinical trials aims to reduce bias in estimates of treatment effect, since outcomes are often open to interpretation, and knowledge of the treatment regimen may affect patient or physician behavior. The impact of blinding on estimates of