Standardizing Clinical Study Designs for Accelerating Drug Development
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STANDARDIZING CLINICAL STUDY DESIGNS FOR ACCELERATING DRUG DEVELOPMENT RAm M. J. DONAHUE, PHD Senior Statistician I. Medical Data Sciences, Glaxo Wellcome, Inc., Research Triangle Park. North Carolina
STEPHEN J. RUBERG,PHD Vice President, North American Biometrics and Data Management, Hoechst Marion Roussel, Kansas City, Missouri
The goal of drug development must be to eliminate from further development those compounds that are not worthy of further investment and to eliminate them as soon as possible. Issues in dealing with early clinical trials in man and questions regarding their necessity are presented. The argument is made that early Phase I and Phase I1 trials, or at least the reasons for running them, must be standardized rigidly across all drugs in a portfolio and that early Phase I1 trials must be made definitive in the patient population of interest. An example of such a scheme is given. A list of intangible benefits of a standardized process is also offered. Key Words: Clinical trial design; Drug development process; Standardization;Drug development cost; Drug development time
INTRODUCTION ESTIMATES OF THE TIME and cost required to bring drugs to market range upwards of 12 years and $250 million (1). One could even make the argument that the cost of bringing a new drug to market ought to be computed as the amount spent in research and development (R & D) each year divided by the number of approvals per year, that is, for a company spending $1 billion on R & D annually and getting one new drug approval ~~~
Presented at the DIA 32nd Annual Meeting ‘The Challenge of Worldwide Pharmaceutical Development in an Era of Regulatory Change: Accelerated Approval with Quality and Contained Cost,” June 8-11, 1996, San Diego, California. Reprint address: Rafe M. J. Donahue, PhD, Senior Statistician I, Medical Data Sciences, Glaxo Wellcome, Inc., Room 17.1455. PO Box 13398, Research Triangle Park, NC 27709-3398.
annually, the cost of drug development is simply $1 billion per drug. Regardless of the method of computation, however, it is not difficult to see that drug development is a costly process. With such a huge outlay of resources into this process, it is imperative to the survival of the companies in this competitive marketplace to maximize the usefulness of all the dollars and time spent on R & D. Statistics has evolved from the study of the science of government to a complex discipline aiding much of modem science. More recent advances in the field include principles of quality and strategic decision making. All of statistics recognizes the presence of uncertainly in future outcomes and provides answers that seek to minimize the effects of variability and quantitate the likelihood of these outcomes. Within the context of drug development, statistics has traditionally taken a role in clin-
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Rafe M.J. Donahue and Stephen J. Ruberg
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