Sample size justification in phase III/IV clinical trials

被引：2

作者：

Richardson, D ^{[1
]}

Leurgans, S ^{[1
]}

机构：

[1] AAASPS Data Management Ctr, Chicago, IL 60612 USA

来源：

NEUROEPIDEMIOLOGY | 1998年 / 17卷 / 02期

关键词：

sample size; power; clinical trial design;

D O I：

10.1159/000026154

中图分类号：

R1 [预防医学、卫生学];

学科分类号：

1004 ; 120402 ;

摘要：

A sample size justification is often a key component in securing funding to conduct a clinical trial. Sample size computations typically require supplying values of parameters that are unknown and subject to misspecification. As an alternative, we advocate a power analysis approach based on a range of reasonable values for such parameters. We illustrate this approach in the context of a secondary stroke prevention trial.

引用

页码：63 / 66

页数：4

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