COMET Initiative | Heterogeneity in Definitions of Endpoints for Clinical Trials of Ulcerative Colitis: A Systematic Review for Development of a Core Outcome Set

Heterogeneity in Definitions of Endpoints for Clinical Trials of Ulcerative Colitis: A Systematic Review for Development of a Core Outcome Set

Background & AimsAdvances in development of therapeutic agents for ulcerative colitis (UC) have been paralleled by innovations in trial design. It would be useful to identify a core outcome set, to standardize outcome definitions for efficacy and safety in clinical trials. We performed a systematic review of efficacy and safety outcomes reported in placebo-controlled randomized controlled trials of patients with UC.

Contributors

Ma, Christopher Panaccione, Remo Fedorak, Richard N. Parker, Claire E. Nguyen, Tran M. Khanna, Reena Siegel, Corey A. Peyrin-Biroulet, Laurent D’Haens, Geert Sandborn, William J. Feagan, Brian G. Jairath, Vipul

Publication

Journal: Clinical Gastroenterology and Hepatology
Volume:
Issue:
Pages: -
Year: 2018
DOI: 10.1016/j.cgh.2017.08.025

Further Study Information

Current Stage: Not Applicable
Date:
Funding source(s):

Health Area

Disease Category: Gastroenterology

Disease Name: Crohn's disease, Inflammatory bowel disease (IBD), Ulcerative colitis

Target Population

Age Range: 18 - 100

Sex: Either

Nature of Intervention: Any

Stakeholders Involved

- None

Study Type

- Systematic review of outcomes measured in trials

Method(s)

- Systematic review