Stopping Trials Early for Benefit — Too Good to Be True?

The practice of stopping randomized clinical trials (RCTs) early for benefit overestimates treatment effects, accrues inadequate data on adverse events, and can lead to misguided treatment recommendations. The number of trials that were stopped early for benefit has increased markedly since 1990 (JAMA 2005; 294:2203). Motives for stopping a trial early include a perceived ethical obligation to offer the treatment to participants and lower trial costs. However, might investigators have less noble motives?

In this systematic review, Italian investigators analyzed 25 RCTs in which new anticancer treatments were tested and that were stopped early for benefit. In 22 studies, the interim endpoint that drove trial truncation was the same endpoint t…