Clinical trials with an adaptive choice of hypotheses

被引：9

作者：

Hommel, G

Kropf, S

机构：

[1] Univ Mainz, Inst Med Stat & Dokumentat, D-55101 Mainz, Germany

[2] Univ Leipzig, Coordinat Ctr Clin Trials, Leipzig, Germany

来源：

DRUG INFORMATION JOURNAL | 2001年 / 35卷 / 04期

关键词：

adaptive design; group-sequential design; closure test; multiple endpoints; a priori ordered hypotheses;

D O I：

10.1177/009286150103500438

中图分类号：

R19 [保健组织与事业（卫生事业管理）];

学科分类号：

摘要：

In a clinical trial with an adaptive interim analysis it is possible to modify not only the design, but even the hypothesis(es) of interest, in a formally correct manner Two examples of clinical trials are described where modifications of hypotheses are based on substantial scientific reasons. Generally, it is emphasized that the danger of manipulation caused by flexible designs must be controlled by very restrictive guidelines.

引用

页码：1423 / 1429

页数：7

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