0
Scientific Articles   |    
The Dangers of Stopping a Trial Too Early
Matthias Briel, MD, MSc1; Dirk Bassler, MD, MSc2; Amy T. Wang, MD3; Gordon H. Guyatt, MD, MSc4; Victor M. Montori, MD, MSc3
1 Basel Institute for Clinical Epidemiology and Biostatistics, University Hospital Basel, Helbelstrasse 10, 4031, Basel, Switzerland
2 Department of Neonatology, Center for Pediatric Clinical Studies, University Children’s Hospital Tuebingen, Cawler Strasse 7, 72076 Tuebingen, Germany
3 Knowledge and Evaluation Research Unit, Mayo Clinic, Plummer 3-35, 200 First Street S.W., Rochester, MN 55905. Email address for V.M. Montori: kerunit@mayo.edu
4 Department of Clinical Epidemiology and Biostatistics, McMaster University, HSC 2C, 1200 Main Street West, Hamilton, ON L8L 2X2, Canada
View Disclosures and Other Information
Disclosure: None of the authors received payments or services, either directly or indirectly (i.e., via his or her institution), from a third party in support of any aspect of this work. None of the authors, or their institution(s), have had any financial relationship, in the thirty-six months prior to submission of this work, with any entity in the biomedical arena that could be perceived to influence or have the potential to influence what is written in this work. Also, no author has had any other relationships, or has engaged in any other activities, that could be perceived to influence or have the potential to influence what is written in this work. The complete Disclosures of Potential Conflicts of Interest submitted by authors are always provided with the online version of the article.

  • Disclosure statement for author(s): PDF

Investigation performed at the Mayo Clinic, Rochester, Minnesota, and McMaster University, Hamilton, Ontario, Canada


Copyright © 2012 by The Journal of Bone and Joint Surgery, Inc.
J Bone Joint Surg Am, 2012 Jul 18;94(Suppl 1(E)):56-60. doi: 10.2106/JBJS.K.01412
5 Recommendations (Recommend) | 3 Comments | Saved by 3 Users Save Case

Abstract

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.

Figures in this Article
    Sign In to Your Personal ProfileSign In To Access Full Content
    Not a Subscriber?
    Get online access for 30 days for $35
    New to JBJS?
    Sign up for a full subscription to both the print and online editions
    Register for a FREE limited account to get full access to all CME activities, to comment on public articles, or to sign up for alerts.
    Register for a FREE limited account to get full access to all CME activities
    Have a subscription to the print edition?
    Current subscribers to The Journal of Bone & Joint Surgery in either the print or quarterly DVD formats receive free online access to JBJS.org.
    Forgot your password?
    Enter your username and email address. We'll send you a reminder to the email address on record.

     
    Forgot your username or need assistance? Please contact customer service at subs@jbjs.org. If your access is provided
    by your institution, please contact you librarian or administrator for username and password information. Institutional
    administrators, to reset your institution's master username or password, please contact subs@jbjs.org

    References

    Accreditation Statement
    These activities have been planned and implemented in accordance with the Essential Areas and policies of the Accreditation Council for Continuing Medical Education (ACCME) through the joint sponsorship of the American Academy of Orthopaedic Surgeons and The Journal of Bone and Joint Surgery, Inc. The American Academy of Orthopaedic Surgeons is accredited by the ACCME to provide continuing medical education for physicians.
    CME Activities Associated with This Article
    Submit a Comment
    Please read the other comments before you post yours. Contributors must reveal any conflict of interest.
    Comments are moderated and will appear on the site at the discretion of JBJS editorial staff.

    * = Required Field
    (if multiple authors, separate names by comma)
    Example: John Doe





    Related Content
    The Journal of Bone & Joint Surgery
    JBJS Case Connector
    Topic Collections
    Related Audio and Videos
    PubMed Articles
    Clinical Trials
    Readers of This Also Read...
    JBJS Jobs
    03/05/2014
    OK - The University of Oklahoma
    04/02/2014
    WV - Charleston Area Medical Center
    11/15/2013
    LA - Ochsner Health System
    05/03/2012
    CA - UCLA/OH Department of Orthopaedic Surgery