Departures from the Protocol During Conduct of a Clinical Trial: A Pattern from the Data Record Consistent with a Learning Curve

摘要

ObjectiveRecognition of learning curves in medical skill acquisition has enhanced patient safety through improved training techniques. Clinical trials research has not been similarly scrutinized. We retrospectively evaluated VALIANT, a large multinational, pragmatic, randomized, double-blind, multicenter trial, for evidence of research conduct consistent with a performance “learning curve.”