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\x85should 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. |