Outcome measurement in clinical trials for Ulcerative Colitis: towards standardisation

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 au...

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Bibliographic Details
Published in:Current controlled trials in cardiovascular medicine 2007-06, Vol.8 (1), p.17-17, Article 17
Main Authors: Cooney, Rachel M, Warren, Bryan F, Altman, Douglas G, Abreu, Maria T, Travis, Simon P L
Format: Article
Language:English
Subjects:
Clinical trials
Endoscopy
Erythema
Fecal incontinence
Inflammatory bowel disease
Laboratories
Light
Methods
Outcome and process assessment (Health Care)
Patient outcomes
Quality of life
Remission (Medicine)
Review
Rheumatology
Ulcerative colitis
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Summary: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.
ISSN:1745-6215
1745-6215
DOI:10.1186/1745-6215-8-17