Pharmaceutical Industry, Statistics In
Abstract
The role of the statistician is traced from early, basic research through the various stages of drug development leading to phase III clinical trials and phase IV postmarketing surveillance. Specific areas of activity, and statistical topics of particular interest, are listed. Examples are taken from the development of drug for treating asthma, and work on project prioritization. Future trends will be affected by financial constraints, by a need to specialize that may lead to work being done by contract research organizations, by the need for speed, and by the need for marketing to be more “evidence-based”.