Silent protocol modifications in multiple sclerosis clinical trials: a registry-based cross-sectional study.

Abstract

Changes in the original protocol of clinical trials should be clearly declared to the readers of journal publications. Otherwise, they can lead to selective outcome reporting bias or distort the appropriate judgement of the study's external validity and statistical power, among other problems. To identify silent protocol modifications in phase III and IV clinical trials examining multiple sclerosis (MS) drugs that have been carried out between 2010 and mid-2023. Comparative analysis of ClinicalT