Projection of power and events in clinical trials with a time-to-event outcome

被引：5

作者：

Royston, Patrick ^{[1
,2
]}

Barthel, Friederike M-S ^{[3
]}

机构：

[1] Hub Trials Methodol Res, MRC Clin Trials Unit, London, England

[2] UCL, London, England

[3] GlaxoSmithKline Inc, Oncol Res & Dev, Uxbridge, Middx, England

来源：

STATA JOURNAL | 2010年 / 10卷 / 03期

基金：

英国医学研究理事会;

关键词：

st0013_2; artpep; artbin; artsurv; artmenu; randomized controlled trial; time-to-event outcome; power; number of events; projection; ARTPEP; ART; SAMPLE-SIZE; SURVIVAL;

D O I：

10.1177/1536867X1001000306

中图分类号：

O1 [数学]; C [社会科学总论];

学科分类号：

03 ; 0303 ; 0701 ; 070101 ;

摘要：

In 2005, Barthel, Royston, and Babiker presented a menu-driven Stata program under the generic name of ART (assessment of resources for trials) to calculate sample size and power for complex clinical trial designs with a time-to-event or binary outcome. In this article, we describe a Stata tool called ARTPEP, which is intended to project the power and events of a. trial with a time-to-event outcome into the future given patient accrual figures so far and assumptions about event rates and other defining parameters. ARTPEP has been designed to work closely with the ART program and has an associated dialog box. We illustrate the use of ARTPEP with data from a phase III trial in esophageal cancer.

引用

页码：386 / 394

页数：9

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