Developing Information for Health-Care Decision Makers

Abstract

One of the major developments in clinical research over the last several years has been the integration of economic evaluation into Phase III clinical protocols. This new development is a result of the recognition that new clinical products face a new set of financial hurdles in the marketplace. Traditional evaluation of pharmaceutical products has focused on safety and efficacy for licensure or approval. Now, concurrent with these decisions, health policy makers and formulary managers are making decisions about reimbursement for new technologies and therapies. These decisions are centralized in countries with national health insurance programs but occur across a diverse audience in the United States, including hospitals, health maintenance organizations (HMOs) or pharmaceutical benefit managers, and employers.