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

Stuart J. Pocock; Tim C. Clayton; Gregg W. Stone

doi:10.1016/j.jacc.2015.10.051

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

Stuart J. Pocock, Tim C. Clayton, Gregg W. Stone

Research output: Contribution to journal › Review article › peer-review

51 Scopus citations

Abstract

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.

Original language	English
Pages (from-to)	2886-2898
Number of pages	13
Journal	Journal of the American College of Cardiology
Volume	66
Issue number	25
DOIs	https://doi.org/10.1016/j.jacc.2015.10.051
State	Published - 29 Dec 2015
Externally published	Yes

Keywords

Data Monitoring Committees
adaptive designs
factorial designs
noninferiority trials
randomized controlled trials as topic
statistical stopping guidelines
strategy trials

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10.1016/j.jacc.2015.10.051

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abstract = "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.",

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

Abstract

Keywords

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