SEQUENTIAL MONITORING OF CLINICAL-TRIALS - THE ROLE OF INFORMATION AND BROWNIAN-MOTION

Sequential monitoring has been a topic of major interest in clincal tr ials methodology over the past two decades. This paper presents a unif ied conceptual framework for sequential monitoring that covers a wide variety of monitoring procedures in a wide variety of clinical trial s ettings. The central elements of this framework consist of a suitable concept of statistical information and a scheme for using this concept as a basis for summarizing the accumulating results of a trial in a s tandardized form, through a stochastic process that can be shown to ap proximate classical Brownian motion. The ideas are developed in a simp le step-by-step fashion and illustrated by several practical examples.