Considerations on what constitutes a ‘qualified statistician’ in regulatory guidelines
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 C...
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| Main Authors: | , , , |
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| Format: | Article (Journal) |
| Language: | English |
| Published: |
2012
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| In: |
Statistics in medicine
Year: 2012, Volume: 31, Issue: 11/12, Pages: 1303-1305 |
| ISSN: | 1097-0258 |
| DOI: | 10.1002/sim.4345 |
| Online Access: | Verlag, Volltext: http://dx.doi.org/10.1002/sim.4345 Verlag, Volltext: https://onlinelibrary.wiley.com/doi/abs/10.1002/sim.4345 
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| Author Notes: | Christoph Gerlinger, Lutz Edler, Tim Friede, Meinhard Kieser, Christos T. Nakas, Martin Schumacher, Jørgen Seldrup and Norbert Victor |
| Summary: | 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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| Item Description: | Published: 21 September 2011 Gesehen am 07.05.2018 |
| Physical Description: | Online Resource |
| ISSN: | 1097-0258 |
| DOI: | 10.1002/sim.4345 |