Strategies for Economic Assessment during the Development of New Drugs

Abstract

One of the fastest growing areas in the economic assessment of new drugs is the incorporation of economic analyses into Phase III clinical trials. These assessments quantify the cost of care for each treatment studied in the trial, evaluate whether the costs of each study treatment differ, and compare the differences in cost and patient outcome of each treatment. An economic assessment in a Phase III trial is one of the best ways to make an early decision about the economic viability of a new drug.

The ideal assessment measures all of the health care costs of all patients in the trial regardless of why the costs were incurred, but this approach is expensive; tradeoffs are often used to make the study more feasible. Several issues should be considered in the design and planning of an economic assessment, such as determining the proportion of total costs to include, identifying which patients will contribute data, identifying care provided by nonstudy sites, determining the format of the collected economic data, and determining the definition of costs. Other issues involved in designing an economic assessment include procedures for implementing the study, analysis methods, and factors influencing the generalizability of the study's findings.