Validating an automated outcomes surveillance application using data from a terminated randomized, controlled trial (OPUS [TIMI-16]).

We sought to validate an automated outcomes surveillance system (DELTA) using OPUS (TIMI-16), a multi-center randomized, controlled trial that was stopped early due to elevated mortality in one of the two intervention arms. Methodologies that were incorporated into the application (Statistical Process Control [SPC] and Bayesian Updating Statistics [BUS]) were compared with standard Data Safety Monitoring Board (DSMB) protocols.