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一项关于关节炎中止痛药的序贯试验:与对照组进行多重比较以及区间删失生存数据的问题。

A sequential trial of pain killers in arthritis: issues of multiple comparisons with control and of interval-censored survival data.

作者信息

Whitehead J, Thomas P

机构信息

Medical and Pharmaceutical Statistics Research Unit, University of Reading, U.K.

出版信息

J Biopharm Stat. 1997 Jul;7(3):333-53. doi: 10.1080/10543409708835192.

Abstract

A large clinical comparison of pain killers used in the treatment of arthritis was conducted using a sequential design. The trial presented two major challenges: there were three treatments to be compared, and patients were assessed annually for up to 7 years. Treatment comparisons were made by selecting appropriate pairwise comparisons, to which standard theory could be applied. Rules concerning actions to take in the event of each stopping criterion being reached were evaluated by simulation. The annual assessments were used to create an interval-censored survival time: the year during which "disease progression" first occurred.

摘要

采用序贯设计对用于治疗关节炎的止痛药物进行了一项大型临床比较研究。该试验面临两个主要挑战:要比较三种治疗方法,并且对患者进行长达7年的年度评估。通过选择合适的成对比较来进行治疗方法比较,这样就可以应用标准理论。通过模拟评估了在达到每个停止标准时应采取的行动规则。年度评估用于创建区间删失生存时间:即“疾病进展”首次出现的年份。

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