LAUSR

There are different reasons to include futility monitoring in clinical trials. We often think of futility monitoring as being planned for business decisions, to limit time and money in a trial that will likely fail its primary objective. But there are also public health and ethical reasons for conducting, or not conducting, futility monitoring in clinical trials. Important considerations in futility monitoring include maintenance of trial integrity, the methods used and their operating characteristics, and the interplay with safety monitoring. This article will discuss some of the whys, whens, and hows of futility monitoring.