Economic analyses in clinical trials for cooperative groups: operational considerations.

Clinical trials have served as valuable tools for evaluating new therapeutic strategies in the treatment of cancer. Traditionally, new pharmaceuticals and procedures have been appraised on the basis of effectiveness, efficacy, and safety. Recently, economic concerns have become increasingly important when considering treatment strategies for cancer patients. The national emphasis on assessing the costs of health care has focused primarily on the cost-effectiveness of resource allocation. Policy makers are exhibiting greater interest in economic data to supplement clinical data of new procedures and pharmaceutical agents before the approval and widespread application of such methodologies. Clinical trials have increasingly become viewed as a proper setting for such economic analyses. In this paper, we review operational details for carrying out economic analyses of clinical trials being conducted in the cancer cooperative group setting.