Outcome measurement in clinical trials for Ulcerative Colitis: towards standardisation

被引：104

作者：

Cooney, Rachel M.

Warren, Bryan F.

Altman, Douglas G.

Abreu, Maria T.

Travis, Simon P. L. ^{[1
]}

机构：

[1] John Radcliffe Hosp, Gastroenterol Unit, Oxford OX3 9DU, England

[2] Univ Oxford, Ctr Stat med, Oxford, England

[3] Mt Sinai Hosp, Ctr Inflammatory Bowel Dis, New York, NY 10029 USA

来源：

TRIALS | 2007年 / 8卷 / 1期

关键词：

D O I：

10.1186/1745-6215-8-17

中图分类号：

R-3 [医学研究方法]; R3 [基础医学];

学科分类号：

1001 ;

摘要：

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.

引用

页数：9

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