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J Am Coll Cardiol. 2015 Dec 29;66(25):2886-2898. 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.

Author information

1
Department of Medical Statistics, London School of Hygiene and Tropical Medicine, London, United Kingdom. Electronic address: stuart.pocock@lshtm.ac.uk.
2
Department of Medical Statistics, London School of Hygiene and Tropical Medicine, London, United Kingdom.
3
Columbia University Medical Center, New York-Presbyterian Hospital, and the Cardiovascular Research Foundation, New York, New York.

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.

KEYWORDS:

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

PMID:
26718676
DOI:
10.1016/j.jacc.2015.10.051
[Indexed for MEDLINE]
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