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 journalReview articlepeer-review

47 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 languageEnglish
Pages (from-to)2886-2898
Number of pages13
JournalJournal of the American College of Cardiology
Volume66
Issue number25
DOIs
StatePublished - 29 Dec 2015
Externally publishedYes

Keywords

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

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