Is There a Price to Pay for Short-Term Savings in the Clinical Development of New Pharmaceutical Products?
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Is There a Price to Pay for Short-Term Savings in the Clinical Development of New Pharmaceutical Products?
Shelby D. Reed, PhD Center for Clinical and Genetic Economics, Duke University Medical Center, Durham, North Carolina Robert M. Califf, MD Duke Clinical Research Institute, Duke University Medical Center, Durham, North Carolina Kevin A. Schulman, MD Center for Clinical and Genetic Economics, Duke University Medical Center, Durham, North Carolina
Key Words Clinical trials; Drug approval; Research design; Health care economics and organizations Correspondence Address Shelby D. Reed, PhD Center for Clinical and Genetic Economics, Duke Clinical Research Institute, PO Box 17969, Durham, NC 27715 (e-mail: [email protected]).
Clinical development of new pharmaceutical compounds has historically been geared toward meeting the information demands of regulatory agencies while minimizing the cost and duration of the drug development process. One strategy for meeting these objectives has been the globalization of the clinical research enterprise. However, the data collected in multinational clinical trials may be suboptimal for entities that make health care reimbursement decisions. As reimbursement authorities begin to demand highquality data, the design of efficient clinical development programs will become more complex. In this article, we use a model of net present value to explore relationships between the cost and duration of clinical trials and sales for a hypothetical
INTRODUCTION Clinical development of a new pharmaceutical product represents an effort to construct a comprehensive information package for regulatory approval or licensure. Clinical trials are a major component of this process. Because the information needs of regulatory agencies focus primarily on the evaluation of biological hypotheses, those needs are generally consistent around the world (1,2). Tailoring the clinical development program to the needs of regulatory agencies has been challenged recently by the desire of public and private entities to review clinical data on new technologies for purposes of reimbursement assessment. However, the information needs of reimbursement authorities are not based on assessments of biologic hypotheses but, rather, on interactions of biology with the clinical practice of medicine. For reimbursement authorities, the essential question is not whether the product achieves the labeled indication in a clinical trial population but whether the product will have the labeled clinical bene-
drug in three markets defined by size, price sensitivity, and the relationship between the probability of reimbursement and the quality of the information. We demonstrate how designing clinical trials to meet short-term objectives of minimizing cost and duration can have negative long-term financial consequences in environments where reimbursement decisions are sensitive to the quality of the data produced. To the extent that reimbursement authorities discount evidence collected in multinational clinical trials, those
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