Challenging Issues in Clinical Trial Design Part 4 of a 4-Part Series on Statistics for Clinical Trials

被引：45

作者：

Pocock, Stuart J. ^{[1
]}

Clayton, Tim C. ^{[1
]}

Stone, Gregg W. ^{[2
,3
]}

机构：

[1] Univ London London Sch Hyg & Trop Med, Dept Med Stat, London WC1E 7HT, England

[2] Columbia Univ, Med Ctr, New York Presbyterian Hosp, New York, NY USA

[3] Columbia Univ, Med Ctr, Cardiovasc Res Fdn, New York, NY USA

来源：

JOURNAL OF THE AMERICAN COLLEGE OF CARDIOLOGY | 2015年 / 66卷 / 25期

关键词：

adaptive designs; Data Monitoring Committees; factorial designs; noninferiority trials; randomized controlled trials as topic; statistical stopping guidelines; strategy trials; AORTIC-VALVE-REPLACEMENT; BARE-METAL STENTS; RANDOMIZED-TRIALS; DOUBLE-BLIND; HIGH-RISK; ANTIPLATELET THERAPY; PLATELET INHIBITION; MEDICAL THERAPY; ELUTING STENTS; INTERVENTION;

D O I：

10.1016/j.jacc.2015.10.051

中图分类号：

R5 [内科学];

学科分类号：

1002 ; 100201 ;

摘要：

As a sequel to last week's paper on the fundamentals of clinical trial design, this paper tackles related controversial issues: noninferiority trials, the value of factorial designs, the importance and challenges of strategy trials, Data Monitoring Committees (including when to stop a trial early), and the role of adaptive designs. All topics are illustrated by relevant examples from cardiology trials. (C) 2015 by the American College of Cardiology Foundation.

引用

页码：2886 / 2898

页数：13

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