Outcome measurement in clinical trials for Ulcerative Colitis: towards standardisation.
Outcome measurement in clinical trials for Ulcerative Colitis: towards standardisation.
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DOI：
10.1186/1745-6215-8-17
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发表时间：
2007-06-25
期刊：
影响因子：
2.5
通讯作者：
Travis SP
中科院分区：
文献类型：
--
作者：
Cooney RM;Warren BF;Altman DG;Abreu MT;Travis SP
新药治疗的临床试验需要明确的患者选择标准和商定的疾病缓解定义。这一原则已成功应用于风湿病学领域，其中商定的疾病评分系统允许多中心合作，并促进了跨治疗中心的审计。不幸的是，在溃疡性结肠炎中缺乏这种共识。已经开发了13个评分系统，但没有一个得到适当的验证。大多数试验选择不同的终点和活动指数，使得不同试验的结果非常难以比较。在内镜、临床和组织学评分系统上达成国际共识至关重要，因为这些是用于确定溃疡性结肠炎临床试验入选标准和结局测量的关键组成部分。随着多种新疗法的开发，迫切需要达成共识。
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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