One-Sided Sequential Stopping Boundaries for Clinical Trials: A Decision- Theoretic Approach

Abstract

We address one-sided stopping rules for clinical trials, or more generally, drug development programs, from a decision-theoretic point of view. If efficacy results are sufficiently negative then the trial will be stopped. But regardless of how positive the efficacy results are, the trial will continue in order to demonstrate safety. We show how sequential decisions should be made by a pharmaceutical company attempting to maximize its expected profits.