Comparison of intention-to-treat and per-protocol results in non-inferiority trials: a methodological review protocol

INTRODUCTION: Non-inferiority (NI) trial designs, which assess whether an experimental intervention is no worse than the standard of care, have become increasingly prevalent in recent years. Current thinking suggests that the intention-to-treat (ITT) analysis is considered anti-conservative in the presence of protocol violations when compared with the per-protocol (PP) analysis. METHODS AND ANALYSIS: We aim to conduct a methodological review of …