The relevance of searching for effects under a clinical-trial lamppost: a key issue.
In economic evaluations of new medical technologies, analysts often need to use data from randomized controlled trials. Trials are designed to achieve high internal validity; however, their selected populations and often highly artificial environments may imply low external validity. Thus, the use of trial data in an economic evaluation may bias the results, since economic evaluation is concerned not with theoretical capability in a trial but with likely performance in the practice environment. This paper indicates both the probable bias of one aspect of artificiality in the trial environment--selected populations--and a method of adjusting the analysis so that results will be more likely to reflect actual practice. The judicious use of extra-trial information can be used to correct the biases of clinical trials.
Division of Pharmaceutical Policy and Evaluative Sciences, School of Pharmacy, University of North Carolina at Chapel Hill 27599-7360, USA.
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Rittenhouse
D000911:Antibodies, Monoclonal / Q000191:economics; D061067:Antibodies, Monoclonal, Humanized; D003362:Cost-Benefit Analysis; D016527:Drug Costs; D006801:Humans; D018803:Models, Economic; D011358:Product Surveillance, Postmarketing; D012372:ROC Curve; D016032:Randomized Controlled Trials as Topic; D015203:Reproducibility of Results; D015983:Selection Bias; D018805:Sepsis / Q000188:drug therapy; D016019:Survival Analysis
D000911:Antibodies, Monoclonal; D061067:Antibodies, Monoclonal, Humanized; C068069:nebacumab