The use of interim data and Data Monitoring Committee recommendations in randomized controlled trial reports: frequency, implications and potential sources of bias

BACKGROUND: Interim analysis of accumulating trial data is important to protect participant safety during randomized controlled trials (RCTs). Data Monitoring Committees (DMCs) often undertake such analyses, but their widening role may lead to extended use of interim analysis or recommendations that...

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Main Authors: Tharmanathan, Puvan, Calvert, Melanie, Hampton, John, Freemantle, Nick
格式: Artigo
語言:English
出版: BioMed Central 2008
主題:
Correspondence
在線閱讀:https://ncbi.nlm.nih.gov/pmc/articles/PMC2279143/
https://ncbi.nlm.nih.gov/pubmed/18366697
https://ncbi.nlm.nih.govhttp://dx.doi.org/10.1186/1471-2288-8-12
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spelling pubmed-22791432008-04-03 The use of interim data and Data Monitoring Committee recommendations in randomized controlled trial reports: frequency, implications and potential sources of bias Tharmanathan, Puvan Calvert, Melanie Hampton, John Freemantle, Nick BMC Med Res Methodol Correspondence BACKGROUND: Interim analysis of accumulating trial data is important to protect participant safety during randomized controlled trials (RCTs). Data Monitoring Committees (DMCs) often undertake such analyses, but their widening role may lead to extended use of interim analysis or recommendations that could potentially bias trial results. METHODS: Systematic search of eight major publications: Annals of Internal Medicine, BMJ, Circulation, CID, JAMA, JCO, Lancet and NEJM, including all randomised controlled trials (RCTs) between June 2000 and May 2005 to identify RCTs that reported use of interim analysis, with or without DMC involvement. Recommendations made by the DMC or based on interim analysis were identified and potential sources of bias assessed. Independent double data extraction was performed on all included trials. RESULTS: We identified 1772 RCTs, of which 470 (27%; 470/1772) reported the use of a DMC and a further 116 (7%; 116/1772) trials reported some form of interim analysis without explicit mention of a DMC. There were 28 trials (24 with a formal DMC), randomizing a total of 79396 participants, identified as recommending changes to the trial that may have lead to biased results. In most of these, some form of sample size re-estimation was recommended with four trials also reporting changes to trial endpoints. The review relied on information reported in the primary publications and methods papers relating to the trials, higher rates of use may have occurred but not been reported. CONCLUSION: The reported use of interim analysis and DMCs in clinical trials has been increasing in recent years. It is reassuring that in most cases recommendations were made in the interest of participant safety. However, in practice, recommendations that may lead to potentially biased trial results are being made. BioMed Central 2008-03-20 /pmc/articles/PMC2279143/ /pubmed/18366697 http://dx.doi.org/10.1186/1471-2288-8-12 Text en Copyright © 2008 Tharmanathan et al; licensee BioMed Central Ltd. http://creativecommons.org/licenses/by/2.0 This is an Open Access article distributed under the terms of the Creative Commons Attribution License ( (http://creativecommons.org/licenses/by/2.0) ), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.
institution US National Library of Medicine
collection PubMed Central
language English
format Article
topic Correspondence
spellingShingle Correspondence
Tharmanathan, Puvan
Calvert, Melanie
Hampton, John
Freemantle, Nick
The use of interim data and Data Monitoring Committee recommendations in randomized controlled trial reports: frequency, implications and potential sources of bias
description BACKGROUND: Interim analysis of accumulating trial data is important to protect participant safety during randomized controlled trials (RCTs). Data Monitoring Committees (DMCs) often undertake such analyses, but their widening role may lead to extended use of interim analysis or recommendations that could potentially bias trial results. METHODS: Systematic search of eight major publications: Annals of Internal Medicine, BMJ, Circulation, CID, JAMA, JCO, Lancet and NEJM, including all randomised controlled trials (RCTs) between June 2000 and May 2005 to identify RCTs that reported use of interim analysis, with or without DMC involvement. Recommendations made by the DMC or based on interim analysis were identified and potential sources of bias assessed. Independent double data extraction was performed on all included trials. RESULTS: We identified 1772 RCTs, of which 470 (27%; 470/1772) reported the use of a DMC and a further 116 (7%; 116/1772) trials reported some form of interim analysis without explicit mention of a DMC. There were 28 trials (24 with a formal DMC), randomizing a total of 79396 participants, identified as recommending changes to the trial that may have lead to biased results. In most of these, some form of sample size re-estimation was recommended with four trials also reporting changes to trial endpoints. The review relied on information reported in the primary publications and methods papers relating to the trials, higher rates of use may have occurred but not been reported. CONCLUSION: The reported use of interim analysis and DMCs in clinical trials has been increasing in recent years. It is reassuring that in most cases recommendations were made in the interest of participant safety. However, in practice, recommendations that may lead to potentially biased trial results are being made.
author Tharmanathan, Puvan
Calvert, Melanie
Hampton, John
Freemantle, Nick
author_facet Tharmanathan, Puvan
Calvert, Melanie
Hampton, John
Freemantle, Nick
author_sort Tharmanathan, Puvan
title The use of interim data and Data Monitoring Committee recommendations in randomized controlled trial reports: frequency, implications and potential sources of bias
title_short The use of interim data and Data Monitoring Committee recommendations in randomized controlled trial reports: frequency, implications and potential sources of bias
title_full The use of interim data and Data Monitoring Committee recommendations in randomized controlled trial reports: frequency, implications and potential sources of bias
title_fullStr The use of interim data and Data Monitoring Committee recommendations in randomized controlled trial reports: frequency, implications and potential sources of bias
title_full_unstemmed The use of interim data and Data Monitoring Committee recommendations in randomized controlled trial reports: frequency, implications and potential sources of bias
title_sort use of interim data and data monitoring committee recommendations in randomized controlled trial reports: frequency, implications and potential sources of bias
publisher BioMed Central
publisher_facet BioMed Central
publishDate 2008
url https://ncbi.nlm.nih.gov/pmc/articles/PMC2279143/
https://ncbi.nlm.nih.gov/pubmed/18366697
https://ncbi.nlm.nih.govhttp://dx.doi.org/10.1186/1471-2288-8-12
_version_ 1760532905189179392

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