Overestimation of benefit when clinical trials stop early: a simulation study

ConclusionSimulated trials typical of those stopping early for benefit overestimate the true relative risk reduction by roughly 50% (i.e. the true RRR was 2/3 of the observed value). Overestimation was much smaller, and likely unimportant, when simulating large SPRINT-like trials stopping early. Whether trials were large or small, stopped early or not, a minimum 250 events were needed to avoid overestimating relative risk reduction by an absolute 5% or more.

http://link.springer.com/10.1186/s13063-022-06689-9

Source: Trials - September 5, 2022 Category: Research Source Type: clinical trials