Considerations on what constitutes a 'qualified statistician' in regulatory guidelines

被引：7

作者：

Gerlinger, Christoph ^{[1
]}

Edler, Lutz ^{[2
]}

Friede, Tim ^{[3
]}

Kieser, Meinhard ^{[4
]}

Nakas, Christos T. ^{[5
]}

Schumacher, Martin ^{[6
]}

Seldrup, Jorgen ^{[7
]}

Victor, Norbert ^{[4
,8
]}

机构：

[1] Bayer Pharma AG, Global Clin Stat, D-13342 Berlin, Germany

[2] German Canc Res Ctr, Dept Biostat, D-69120 Heidelberg, Germany

[3] Univ Gottingen, D-37073 Gottingen, Germany

[4] Heidelberg Univ, Inst Med Biometry & Informat, D-69120 Heidelberg, Germany

[5] Univ Thessaly, Lab Biometry, GR-38446 Magnisia, Greece

[6] Univ Med Ctr Freiburg, Inst Med Biometry & Med Informat, D-79104 Freiburg, Germany

[7] Quintiles, Ctr Stat Drug Dev, F-67404 Illkirch Graffenstaden, France

[8] ISCB, D-69120 Heidelberg, Germany

来源：

STATISTICS IN MEDICINE | 2012年 / 31卷 / 11-12期

关键词：

qualified statistician; regulatory affairs; ICH; guideline;

D O I：

10.1002/sim.4345

中图分类号：

Q [生物科学];

学科分类号：

07 ; 0710 ; 09 ;

摘要：

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 (C) 2011 John Wiley & Sons, Ltd.

引用

页码：1303 / 1305

页数：3

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