Perioperative randomised controlled trials: to pilot or not to pilot?

Abstract

The science of pilot trials is evolving, and understanding of their role in medical research is increasing. Perioperative randomised controlled trials often test interventions that are inherently multidisciplinary and complex; therefore, there might be compelling reasons to conduct pilot studies to assess feasibility and inform trial design. As pilot studies themselves require resources, investigators should not squander this opportunity; they should design them so that they properly address the sources of uncertainty regarding the success of the definitive trial.