Core Outcome Measures in Effectiveness Trials

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

General Information

Abstract:
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.

Authors:
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:
Further Study Information

Date:
Not stated
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 / type of Intervention
Any

Method(s)

Systematic review

Stakeholders Involved

None

Study Type

Systematic review of outcomes measured in trials

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