Timely Topics in Statistical Methods for Clinical Trials

Clinical trials provide information on the absolute and relative efficacy and side effects of medical treatments. These studies range from the well-designed, randomized controlled trial to a study of a single treat­ ment on a series of patients compared to the responses of previous patients treated another way. Statistical methods and concepts play a central role in the design, conduct, analysis, and reporting of these investigations. This article provides a discussion of current developments in the application of these methods and concepts to clinical investiga­ tions. We have made a detailed review of the literature published from 1976 to 1979 and have provided coverage of the major journals for 1980 and part of 1981. Our bibliography refers to the most recent and important literature. These citations should provide sufficient entry points for a more extensive study. The current literature on statistical applications to clinical trials di­ vides into two primary components: presentation of methodologic devel­ opments and discussion of the controversies associated with choosing