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June 4, 1997

Blinding of Clinical Trials With Concurrent Economic Analysis-Reply

Author Affiliations

Michael Drummond, DPhil University of York Heslington, York, United Kingdom

JAMA. 1997;277(21):1677. doi:10.1001/jama.1997.03540450033018

In Reply.  —We provided 2 examples of nonblinded real-world studies in our article, but we agree that it is artificial to consider a divide between real-world trials and those with high construct validity. Economic analyses require real-world estimates of effect (ie, what will be achieved), rather than the estimates of what can be achieved in the context of doubleblind phase 3 clinical trials. In phase 3 trials, artificial circumstances often may be required to ensure that the trial is estimating what the investigators hope to measure. It is more helpful to consider the degree to which the real world is lost in trials. We are describing a continuum rather than a dichotomy.Standard phase 3 trials ask, "Will it work?" whereas an economic trial asks, "Is it worth doing?" These questions have different design implications, and it is rarely possible to answer both with high validity in the same trial. It may