Futility Monitoring in Clinical Trials

Abstract

At the beginning of a phase III clinical trial, there is great optimism. After all, the phase II trial results were encouraging. Then, early data from the phase III trial trend in the wrong way, but there is still an opportunity for the trend to reverse and become statistically significant by the end. At what point does optimism become denial of reality? How do we decide when a clinical trial is futile? What does futility even mean? This tutorial reviews different concepts and tools for evaluating futility, including conditional and predictive power, reverse conditional power, predicted interval plots, revised unconditional power, and beta spending functions.