| On being the statistician on a Data and Safety Monitoring Board. | |
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MedLine Citation:
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PMID: 10611616 Owner: NLM Status: MEDLINE |
Abstract/OtherAbstract:
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Data and Safety Monitoring Boards (DSMBs) are commonly appointed to monitor emerging data from major clinical trials. This paper describes their organization and remit, and their relationship with other trial committees and structures. The operation of formal stopping rules for safety and efficacy by a DSMB is discussed. The duties of a DSMB, from pre-trial planning through to stopping a study are described in detail, with emphasis on the reporting of information to the DSMB and the reporting of conclusions by the DSMB. The issue of blindness is given prominence and the role of the statistician on the DSMB is explored in detail. |
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Authors:
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J Whitehead |
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Publication Detail:
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Type: Journal Article |
Journal Detail:
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Title: Statistics in medicine Volume: 18 ISSN: 0277-6715 ISO Abbreviation: Stat Med Publication Date: 1999 Dec |
Date Detail:
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Created Date: 2000-03-02 Completed Date: 2000-03-02 Revised Date: 2007-11-15 |
Medline Journal Info:
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Nlm Unique ID: 8215016 Medline TA: Stat Med Country: ENGLAND |
Other Details:
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Languages: eng Pagination: 3425-34 Citation Subset: IM |
Copyright Information:
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Copyright 1999 John Wiley & Sons, Ltd. |
Affiliation:
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Medical and Pharmaceutical Statistics Research Unit, The University of Reading, P.O. Box 240, Earley Gate, Reading RG6 6FN, U.K. J.R.Whitehead@reading.ac.uk |
Export Citation:
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| MeSH Terms | |
Descriptor/Qualifier:
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Adverse Drug Reaction Reporting Systems
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statistics & numerical data* Clinical Trials as Topic / statistics & numerical data* Data Interpretation, Statistical* Drug Monitoring / statistics & numerical data Humans |
From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine
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