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Designing economic evaluations in clinical trials 

Designing economic evaluations in clinical trials
Designing economic evaluations in clinical trials

Dr. Henry A. Glick

, Dr. Jalpa A. Doshi

, Dr. Seema S. Sonnad

, and Dr. Daniel Polsky

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date: 08 March 2021

This chapter describes the gold standard economic evaluation in clinical trials and the tensions that lead to the balancing of ideal versus feasible designs. It also addresses preplanning in preparation for the trial, identification of medical services that will be measured and the price weights (unit costs) that will be used to value medical services, and issues related to the naturalism of the trial. The latter include sample inclusion criteria, use of intention-to-treat principles, and protocol-induced service use and cost. New material has been added that discusses data needed for sample size calculations, published data collection instruments available for use of medical services as well as work loss, and the reliability of respondent recall.

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