Box 7.

Exemplars on reporting adaptation decisions made to the trial in the abstract

Example 1. 2-stage inferential seamless phase 2/3 AD; pre-planned adaptation decisions “A planned interim analysis was conducted for otamixaban dose selection using a pre-specified algorithm (unknown to investigators) … The selected regimen to carry forward was an intravenous bolus of 0.080 mg/kg followed by an infusion of 0.140 mg/kg per hour.” [144] Example 2. Group sequential AD; early stopping decision “The trial was stopped early (at the third interim analysis), according to pre-specified rules, after a median follow-up of 27 months, because the boundary for an overwhelming benefit with LCZ696 had been crossed.” [145]