Conventional evaluation of new medical technologies such as pharmaceutical products includes consideration of efficacy, effectiveness, and safety. The methodology for such analyses is well developed, and studies of safety and efficacy often are required prior to drug marketing. Health care researchers from a variety of disciplines have developed new techniques for the evaluation of the economic effects of clinical care and new medical technologies. Clinicians, pharmacists, economists, epidemiologists, operations researchers, and others have contributed to the field of ‘clinical economics’, an evolving discipline dedicated to the study of how different approaches to patient care and treatment influence the resources consumed in clinical medicine.

The growth of clinical economics has proceeded rapidly as health policymakers have faced a series of decisions about funding new clinical therapies in an era of increasingly constrained health care resources. Assessments of new therapies include an accounting of the resources required for the new therapy, the extent of the substitution of the new resources for existing resources, if any, and the health outcomes that result from therapeutic intervention. Thus, clinical economics includes not only an assessment of the cost of a new therapy, but an assessment of its overall economic and clinical effect.

This chapter discusses the need for applying economic concepts to the study of pharmaceuticals, introduces the concepts of clinical economics and the application of these concepts to pharmaceutical research, reviews some of the methodologic issues addressed by investigators studying the economics of pharmaceuticals, and finally offers examples of this type of research.