Outcome measurement in clinical trials for ulcerative colitis: towards standardisation

TLDR

Clinical trials for ulcerative colitis lack a validated, standardized scoring system, unlike rheumatology, leading to inconsistent endpoints that hinder cross‑trial comparisons. The study aims to establish an international consensus on endoscopic, clinical, and histological scoring systems to standardize entry criteria and outcome measures for ulcerative colitis trials. The authors propose developing consensus scoring systems for endoscopic, clinical, and histological assessment to serve as standardized criteria in ulcerative colitis trials.

Abstract

Abstract Clinical trials on novel drug therapies require clear criteria for patient selection and agreed definitions of disease remission. This principle has been successfully applied in the field of rheumatology where agreed disease scoring systems have allowed multi-centre collaborations and facilitated audit across treatment centres. Unfortunately in ulcerative colitis this consensus is lacking. Thirteen scoring systems have been developed but none have been properly validated. Most trials choose different endpoints and activity indices, making comparison of results from different trials extremely difficult. International consensus on endoscopic, clinical and histological scoring systems is essential as these are the key components used to determine entry criteria and outcome measurements in clinical trials on ulcerative colitis. With multiple new therapies under development, there is a pressing need for consensus to be reached.