Pharmacoeconomics in Clinical Trials: Why Bother?

Abstract

“Why bother with Pharmacoeconomics in Clinical Trials?” In examining the topic, historical and current research challenges, including generalizability of results, statistical power considerations, sample size adequacy, and validity of measurement tools are identified. Despite these hurdles, current pharmacoeconomic information needs warrant that these data indeed be collected in the clinical trials arena.

A framework for conducting future pharmacoeconomic research is presented with emphasis on economic analyses in clinical trials. The first important step involved in planning pharmacoeconomic research is to assess need for such analyses in the clinical trials setting. If a need exists, research should be performed with the following goals: complete integration of pharmacoeconomics in clinical trials, strict adherence to the scientific method, and inclusion of sensitivity analyses. Acquiring pharmacoeconomic information throughout the clinical trials process assists early market confirmation, and will ultimately result in better and well-informed clinical decisions.