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Trials
Published in: Trials 1/2007

Open Access 01-12-2007 | Review

Outcome measurement in clinical trials for ulcerative colitis: towards standardisation

Authors: Rachel M Cooney, Bryan F Warren, Douglas G Altman, Maria T Abreu, Simon PL Travis

Published in: Trials | Issue 1/2007

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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.
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Metadata
Title
Outcome measurement in clinical trials for ulcerative colitis: towards standardisation
Authors
Rachel M Cooney
Bryan F Warren
Douglas G Altman
Maria T Abreu
Simon PL Travis
Publication date
01-12-2007
Publisher
BioMed Central
Published in
Trials / Issue 1/2007
Electronic ISSN: 1745-6215
DOI
https://doi.org/10.1186/1745-6215-8-17

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