Considerations on what constitutes a ‘qualified statistician’ in regulatory guidelines

• Verfasst von: Gerlinger, Christoph [VerfasserIn]
• Verfasst von: Edler, Lutz [VerfasserIn]
• Verfasst von: Kieser, Meinhard [VerfasserIn]
• Verfasst von: Victor, Norbert [VerfasserIn]
• Titel: Considerations on what constitutes a ‘qualified statistician’ in regulatory guidelines
• Verf.angabe: Christoph Gerlinger, Lutz Edler, Tim Friede, Meinhard Kieser, Christos T. Nakas, Martin Schumacher, Jørgen Seldrup and Norbert Victor
• Jahr: 2012
• Umfang: 3 S.
• Fussnoten: Published: 21 September 2011 ; Gesehen am 07.05.2018
• Titel Quelle: Enthalten in: Statistics in medicine
• Ort Quelle: Chichester [u.a.] : Wiley, 1982
• Jahr Quelle: 2012
• Band/Heft Quelle: 31(2012), 11/12, Seite 1303-1305
• ISSN Quelle: 1097-0258
• DOI: doi:10.1002/sim.4345
• Datenträger: Online-Ressource
• Sprache: eng
• Sach-SW: guideline
• Sach-SW: ICH
• Sach-SW: qualified statistician
• Sach-SW: regulatory affairs
• K10plus-PPN: 1574000535

Abstract

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.