The dangers of stopping a trial too early

Matthias Briel, Dirk Bassler, Amy T. Wang, Gordon H. Guyatt, Victor Manuel Montori

Research output: Contribution to journalArticle

14 Citations (Scopus)

Abstract

To ensure that participants in randomized controlled trials are protected from harm, interim analyses and review of results by an independent data monitoring committee have become standard practice. If an analysis of accumulating data partway through a trial reveals an unanticipated degree of benefit or toxicity, or differences in outcomes between the intervention and control groups are so unimpressive that any prospect of a positive result with the planned sample size is extremely unlikely, investigators may stop the trial earlier than originally scheduled. The practice of stopping randomized controlled trials early is, however, problematic, especially if the trial is stopped for apparent benefit. Concerns in trials stopped early for apparent benefit include appropriate interpretation of results and ethical problems concerning trial participants, clinicians, and society as a whole. In this article, we review the epidemiology of trials stopped early and illustrate some of the problems and controversies associated with stopping randomized controlled trials early for apparent benefit. Finally, we offer guidance for clinicians, those running clinical trials, and authors of systematic reviews.

Original languageEnglish (US)
Pages (from-to)56-60
Number of pages5
JournalJournal of Bone and Joint Surgery - Series A
Volume94
Issue numberSUPPL. 1
DOIs
StatePublished - Jul 18 2012

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Randomized Controlled Trials
Clinical Trials Data Monitoring Committees
Sample Size
Epidemiology
Research Personnel
Clinical Trials
Control Groups

ASJC Scopus subject areas

  • Surgery
  • Orthopedics and Sports Medicine
  • Medicine(all)

Cite this

The dangers of stopping a trial too early. / Briel, Matthias; Bassler, Dirk; Wang, Amy T.; Guyatt, Gordon H.; Montori, Victor Manuel.

In: Journal of Bone and Joint Surgery - Series A, Vol. 94, No. SUPPL. 1, 18.07.2012, p. 56-60.

Research output: Contribution to journalArticle

Briel, Matthias ; Bassler, Dirk ; Wang, Amy T. ; Guyatt, Gordon H. ; Montori, Victor Manuel. / The dangers of stopping a trial too early. In: Journal of Bone and Joint Surgery - Series A. 2012 ; Vol. 94, No. SUPPL. 1. pp. 56-60.
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