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Title Problems of stopping trials early.
Author Guyatt GH, Briel M, Glasziou P, Bassler D, Montori VM
Year 2012
Journal BMK
Volume 344
Issue

Pages :e3863.
Publisher

Link_for_PDF_for_Education

Link for Open Access

DOI

Link for DOI

Web_Access_Paper http://www.ncbi.nlm.nih.gov/pubmed/22705814
Contributed_by Erin E. Fox, PhD, University of Texas Health Science Center at Houston
Commentary I chose this article because the negative consequences of stopping a trial early for benefit is not something I have heard discussed frequently. The manuscript is an editorial, but does reference the authors' and others' previous simulation studies and systematic reviews that support these claims. The authors identify problems such as stopping early for benefit may stifle other trials and cause inappropriate practice guidelines to be made with little supporting data subsequently exposing patients to these guidelines. The authors believe that
"the standard for persuading the entire clinical community that further investigation is not ethical…should be extremely stringent, both in terms of the evidence and the plausibility of the results. Such stringent criteria are unlikely to be met before 500 events have accumulated."
I think that this is an important point and should be taken into account more often when a DSMB is considering stopping a trial for benefit.
Additional_Information

Reference_Subject Biostat_Ethics
Disclaimer The views expressed within CTSpedia are those of the author and must not be taken to represent policy or guidance on the behalf of any organization or institution with which the author is affiliated.
Topic revision: r1 - 12 Mar 2013 - 14:16:54 - MaryBanach
 

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