Is There a Price to Pay for Short-Term Savings in the Clinical Development of New Pharmaceutical Products?

Abstract

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 high-quality 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 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 designing clinical trials will need to look beyond globalization as a strategy to minimize trial costs to designs that balance increased trial costs with the ability to provide reimbursement bodies with generalizable data for decision making.