The Prevention and Treatment of Missing Data in Clinical Trials
Missing data in clinical trials can have a major effect on the validity of the inferences that can be drawn from the trial. This article reviews methods for preventing missing data and, failing that, dealing with data that are missing. Background Missing data have seriously compromised inferences fr...
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Veröffentlicht in: | The New England journal of medicine 2012-10, Vol.367 (14), p.1355-1360 |
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container_title | The New England journal of medicine |
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creator | Little, Roderick J D'Agostino, Ralph Cohen, Michael L Dickersin, Kay Emerson, Scott S Farrar, John T Frangakis, Constantine Hogan, Joseph W Molenberghs, Geert Murphy, Susan A Neaton, James D Rotnitzky, Andrea Scharfstein, Daniel Shih, Weichung J Siegel, Jay P Stern, Hal |
description | Missing data in clinical trials can have a major effect on the validity of the inferences that can be drawn from the trial. This article reviews methods for preventing missing data and, failing that, dealing with data that are missing.
Background
Missing data have seriously compromised inferences from clinical trials, yet the topic has received little attention in the clinical-trial community.
1
Existing regulatory guidances
2
–
4
on the design, conduct, and analysis of clinical trials have little specific advice on how to address the problem of missing data. A recent National Research Council (NRC) report
5
on the topic seeks to address this gap, and this article summarizes some of the main findings and recommendations of that report. The authors of this article served on the panel that prepared the report.
Missing data have seriously compromised inferences from clinical trials.
1
For example, . . . |
doi_str_mv | 10.1056/NEJMsr1203730 |
format | Article |
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Background
Missing data have seriously compromised inferences from clinical trials, yet the topic has received little attention in the clinical-trial community.
1
Existing regulatory guidances
2
–
4
on the design, conduct, and analysis of clinical trials have little specific advice on how to address the problem of missing data. A recent National Research Council (NRC) report
5
on the topic seeks to address this gap, and this article summarizes some of the main findings and recommendations of that report. The authors of this article served on the panel that prepared the report.
Missing data have seriously compromised inferences from clinical trials.
1
For example, . . .</description><identifier>ISSN: 0028-4793</identifier><identifier>EISSN: 1533-4406</identifier><identifier>DOI: 10.1056/NEJMsr1203730</identifier><identifier>PMID: 23034025</identifier><identifier>CODEN: NEJMAG</identifier><language>eng</language><publisher>Waltham, MA: Massachusetts Medical Society</publisher><subject>Algorithms ; Biological and medical sciences ; Clinical trials ; Clinical Trials as Topic - standards ; Clinical Trials, Phase III as Topic - standards ; Data Collection - standards ; General aspects ; Intention to Treat Analysis ; Medical sciences ; Missing data ; Prevention and actions ; Public health. Hygiene ; Public health. Hygiene-occupational medicine ; Research Design - standards ; Statistical methods</subject><ispartof>The New England journal of medicine, 2012-10, Vol.367 (14), p.1355-1360</ispartof><rights>Copyright © 2012 Massachusetts Medical Society. All rights reserved.</rights><rights>2015 INIST-CNRS</rights><rights>Copyright © 2012 Massachusetts Medical Society. 2012</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c541t-bf0609554b16ea68681e6c39de57070dd6c9f655086b289a461ae9349b3809c93</citedby><cites>FETCH-LOGICAL-c541t-bf0609554b16ea68681e6c39de57070dd6c9f655086b289a461ae9349b3809c93</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://www.nejm.org/doi/pdf/10.1056/NEJMsr1203730$$EPDF$$P50$$Gmms$$H</linktopdf><linktohtml>$$Uhttps://www.nejm.org/doi/full/10.1056/NEJMsr1203730$$EHTML$$P50$$Gmms$$H</linktohtml><link.rule.ids>230,314,776,780,881,2746,2747,26080,27901,27902,52357,54039</link.rule.ids><backlink>$$Uhttp://pascal-francis.inist.fr/vibad/index.php?action=getRecordDetail&idt=26395645$$DView record in Pascal Francis$$Hfree_for_read</backlink><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/23034025$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Little, Roderick J</creatorcontrib><creatorcontrib>D'Agostino, Ralph</creatorcontrib><creatorcontrib>Cohen, Michael L</creatorcontrib><creatorcontrib>Dickersin, Kay</creatorcontrib><creatorcontrib>Emerson, Scott S</creatorcontrib><creatorcontrib>Farrar, John T</creatorcontrib><creatorcontrib>Frangakis, Constantine</creatorcontrib><creatorcontrib>Hogan, Joseph W</creatorcontrib><creatorcontrib>Molenberghs, Geert</creatorcontrib><creatorcontrib>Murphy, Susan A</creatorcontrib><creatorcontrib>Neaton, James D</creatorcontrib><creatorcontrib>Rotnitzky, Andrea</creatorcontrib><creatorcontrib>Scharfstein, Daniel</creatorcontrib><creatorcontrib>Shih, Weichung J</creatorcontrib><creatorcontrib>Siegel, Jay P</creatorcontrib><creatorcontrib>Stern, Hal</creatorcontrib><title>The Prevention and Treatment of Missing Data in Clinical Trials</title><title>The New England journal of medicine</title><addtitle>N Engl J Med</addtitle><description>Missing data in clinical trials can have a major effect on the validity of the inferences that can be drawn from the trial. This article reviews methods for preventing missing data and, failing that, dealing with data that are missing.
Background
Missing data have seriously compromised inferences from clinical trials, yet the topic has received little attention in the clinical-trial community.
1
Existing regulatory guidances
2
–
4
on the design, conduct, and analysis of clinical trials have little specific advice on how to address the problem of missing data. A recent National Research Council (NRC) report
5
on the topic seeks to address this gap, and this article summarizes some of the main findings and recommendations of that report. The authors of this article served on the panel that prepared the report.
Missing data have seriously compromised inferences from clinical trials.
1
For example, . . .</description><subject>Algorithms</subject><subject>Biological and medical sciences</subject><subject>Clinical trials</subject><subject>Clinical Trials as Topic - standards</subject><subject>Clinical Trials, Phase III as Topic - standards</subject><subject>Data Collection - standards</subject><subject>General aspects</subject><subject>Intention to Treat Analysis</subject><subject>Medical sciences</subject><subject>Missing data</subject><subject>Prevention and actions</subject><subject>Public health. Hygiene</subject><subject>Public health. Hygiene-occupational medicine</subject><subject>Research Design - standards</subject><subject>Statistical methods</subject><issn>0028-4793</issn><issn>1533-4406</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2012</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><sourceid>BEC</sourceid><sourceid>BENPR</sourceid><sourceid>GUQSH</sourceid><sourceid>M2O</sourceid><recordid>eNp1kUtLxDAUhYMoOj6WbqUggpvqTfNos1FkfDM-FuM6pGmqGdp0TDqC_94MMz7BbC4kH-fck4PQLoYjDIwf31_c3gWPMyA5gRU0wIyQlFLgq2gAkBUpzQXZQJshTCAeTMU62sgIEAoZG6DT8YtJHr15M663nUuUq5KxN6pv40XS1cmdDcG65-Rc9SqxLhk21lmtmkhZ1YRttFbHYXaWcws9XV6Mh9fp6OHqZng2SjWjuE_LGjgIxmiJuVG84AU2XBNRGZZDDlXFtag5Y1DwMiuEohwrIwgVJSlAaEG20MlCdzorW1PpuJ1XjZx62yr_Ljtl5e8XZ1_kc_cmSZ7jmDUKHC4FfPc6M6GXrQ3aNI1yppsFiWFuxxife-3_QSfdzLsYL1JFltMsY3MqXVDadyF4U38tg0HOq5G_qon83s8EX_RnFxE4WAIqxA-uvXLahm-OE8E4_cG1bZDOTNp_DD8Awq-f9Q</recordid><startdate>20121004</startdate><enddate>20121004</enddate><creator>Little, Roderick J</creator><creator>D'Agostino, Ralph</creator><creator>Cohen, Michael L</creator><creator>Dickersin, Kay</creator><creator>Emerson, Scott S</creator><creator>Farrar, John T</creator><creator>Frangakis, Constantine</creator><creator>Hogan, Joseph W</creator><creator>Molenberghs, Geert</creator><creator>Murphy, Susan A</creator><creator>Neaton, James D</creator><creator>Rotnitzky, Andrea</creator><creator>Scharfstein, Daniel</creator><creator>Shih, Weichung J</creator><creator>Siegel, Jay P</creator><creator>Stern, Hal</creator><general>Massachusetts Medical Society</general><scope>IQODW</scope><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>0TZ</scope><scope>7RV</scope><scope>7X7</scope><scope>7XB</scope><scope>8AO</scope><scope>8C1</scope><scope>8FE</scope><scope>8FH</scope><scope>8FI</scope><scope>ABUWG</scope><scope>AFKRA</scope><scope>AN0</scope><scope>AZQEC</scope><scope>BBNVY</scope><scope>BEC</scope><scope>BENPR</scope><scope>BHPHI</scope><scope>CCPQU</scope><scope>DWQXO</scope><scope>FYUFA</scope><scope>GHDGH</scope><scope>GNUQQ</scope><scope>GUQSH</scope><scope>HCIFZ</scope><scope>K0Y</scope><scope>LK8</scope><scope>M0R</scope><scope>M0T</scope><scope>M1P</scope><scope>M2M</scope><scope>M2O</scope><scope>M2P</scope><scope>M7P</scope><scope>MBDVC</scope><scope>NAPCQ</scope><scope>PQEST</scope><scope>PQQKQ</scope><scope>PQUKI</scope><scope>PRINS</scope><scope>PSYQQ</scope><scope>Q9U</scope><scope>7X8</scope><scope>5PM</scope></search><sort><creationdate>20121004</creationdate><title>The Prevention and Treatment of Missing Data in Clinical Trials</title><author>Little, Roderick J ; D'Agostino, Ralph ; Cohen, Michael L ; Dickersin, Kay ; Emerson, Scott S ; Farrar, John T ; Frangakis, Constantine ; Hogan, Joseph W ; Molenberghs, Geert ; Murphy, Susan A ; Neaton, James D ; Rotnitzky, Andrea ; Scharfstein, Daniel ; Shih, Weichung J ; Siegel, Jay P ; Stern, Hal</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c541t-bf0609554b16ea68681e6c39de57070dd6c9f655086b289a461ae9349b3809c93</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2012</creationdate><topic>Algorithms</topic><topic>Biological and medical sciences</topic><topic>Clinical trials</topic><topic>Clinical Trials as Topic - standards</topic><topic>Clinical Trials, Phase III as Topic - standards</topic><topic>Data Collection - standards</topic><topic>General aspects</topic><topic>Intention to Treat Analysis</topic><topic>Medical sciences</topic><topic>Missing data</topic><topic>Prevention and actions</topic><topic>Public health. Hygiene</topic><topic>Public health. 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This article reviews methods for preventing missing data and, failing that, dealing with data that are missing.
Background
Missing data have seriously compromised inferences from clinical trials, yet the topic has received little attention in the clinical-trial community.
1
Existing regulatory guidances
2
–
4
on the design, conduct, and analysis of clinical trials have little specific advice on how to address the problem of missing data. A recent National Research Council (NRC) report
5
on the topic seeks to address this gap, and this article summarizes some of the main findings and recommendations of that report. The authors of this article served on the panel that prepared the report.
Missing data have seriously compromised inferences from clinical trials.
1
For example, . . .</abstract><cop>Waltham, MA</cop><pub>Massachusetts Medical Society</pub><pmid>23034025</pmid><doi>10.1056/NEJMsr1203730</doi><tpages>6</tpages><oa>free_for_read</oa></addata></record> |
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issn | 0028-4793 1533-4406 |
language | eng |
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source | MEDLINE; Elektronische Zeitschriftenbibliothek - Frei zugängliche E-Journals; New England Journal of Medicine |
subjects | Algorithms Biological and medical sciences Clinical trials Clinical Trials as Topic - standards Clinical Trials, Phase III as Topic - standards Data Collection - standards General aspects Intention to Treat Analysis Medical sciences Missing data Prevention and actions Public health. Hygiene Public health. Hygiene-occupational medicine Research Design - standards Statistical methods |
title | The Prevention and Treatment of Missing Data in Clinical Trials |
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