| Considerations on what constitutes a 'qualified statistician' in regulatory guidelines. | |
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MedLine Citation:
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PMID: 21948351 Owner: NLM Status: Publisher |
Abstract/OtherAbstract:
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International regulatory guidelines require that a 'qualified statistician' takes responsibility for the statistical aspects of a clinical trial used for drug licensing. No consensus on what constitutes a 'qualified statistician' appears to have been developed so far. The International Society for Clinical Biostatistics is issuing this reflection paper in order to stimulate a discussion on the concept. Copyright © 2011 John Wiley & Sons, Ltd. |
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Authors:
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Christoph Gerlinger; Lutz Edler; Tim Friede; Meinhard Kieser; Christos T Nakas; Martin Schumacher; Jørgen Seldrup; Norbert Victor |
Publication Detail:
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Type: JOURNAL ARTICLE Date: 2011-9-21 |
Journal Detail:
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Title: Statistics in medicine Volume: - ISSN: 1097-0258 ISO Abbreviation: - Publication Date: 2011 Sep |
Date Detail:
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Created Date: 2011-9-27 Completed Date: - Revised Date: - |
Medline Journal Info:
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Nlm Unique ID: 8215016 Medline TA: Stat Med Country: - |
Other Details:
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Languages: ENG Pagination: - Citation Subset: - |
Copyright Information:
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Copyright © 2011 John Wiley & Sons, Ltd. |
Affiliation:
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Bayer Pharma AG, Global Clinical Statistics, D-13342, Berlin, Germany. Christoph.Gerlinger@bayer.com. |
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From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine
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