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

ABSTRACT:

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 NI trials to compare the results from ITT and PP analysis in NI trials. A comprehensive electronic search strategy will be used to identify studies indexed in MEDLINE, Embase and Cochrane Central Register of Controlled Trials databases. We will include 390 NI trials published prior to 31 December 2024. The primary outcomes are the treat

SUBMITTER: Parpia S 

PROVIDER: S-EPMC12666176 | biostudies-literature | 2025 Nov

REPOSITORIES: biostudies-literature