Modeling with Clinical Trial Data: Moving from the Data Researchers Have to the Data Decision Makers Need

Abstract

Pharmacoeconomic models are tools for extrapolating the cost and effectiveness of drugs in regular practice settings based on more limited data collected during clinical trials. Outcome and cost data may be structured as decision trees or as state-transition models, depending on their complexity. Models are useful for increasing insight and for estimating the comparative value of drugs from pre-Phase I through Phase IV of the trial process. They allow the use of a wide range of data sources. The validity of estimates, however, depends on ensuring that all outcome and cost data used in a model reflect populations with similar epidemiology, disease severity, and risk of high cost, who are treated under similar access and practice conditions.