Sequential monitoring of clinical trials: the role of information and Brownian motion

Stat Med. 1993 Apr 30;12(8):753-65. doi: 10.1002/sim.4780120804.

Abstract

Sequential monitoring has been a topic of major interest in clinical trials methodology over the past two decades. This paper presents a unified conceptual framework for sequential monitoring that covers a wide variety of monitoring procedures in a wide variety of clinical trial settings. 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 standardized form, through a stochastic process that can be shown to approximate classical Brownian motion. The ideas are developed in a simple step-by-step fashion and illustrated by several practical examples.

Publication types

  • Research Support, U.S. Gov't, P.H.S.

MeSH terms

  • Biophysical Phenomena
  • Biophysics
  • Clinical Protocols
  • Clinical Trials as Topic*
  • Data Interpretation, Statistical*
  • Humans
  • Likelihood Functions
  • Linear Models
  • Proportional Hazards Models
  • Random Allocation
  • Research Design*
  • Stochastic Processes
  • Survival Rate
  • Time Factors