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Statistics in Biopharmaceutical Research Volume 8, 2016 - Issue 3: Papers from the 2015 ASA Biopharmaceutical Section Statistics Workshop
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Original Articles

Concepts, Methods, and Practical Considerations of Meta-Analysis in Drug Development

Zhenming ShunDepartment of Biostatistics and Programming, Sanofi, Cambridge, MA, USACorrespondence[email protected]
,
Gao LeiDepartment of Biostatistics and Programming, Sanofi, Cambridge, MA, USA
,
Qianying LiuDepartment of Biostatistics and Programming, Sanofi, Cambridge, MA, USA
,
Wei ZhengDepartment of Biostatistics and Programming, Sanofi, Cambridge, MA, USA
,
Hui QuanDepartment of Biostatistics and Programming, Sanofi, Cambridge, MA, USA
&
Simon HitierSanofi Research & Development, Chilly-Mazarin, France
Pages 287-292 | Received 01 Aug 2015, Published online: 16 Sep 2016
 
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ABSTRACT

Meta-analysis is the statistical methodology to combine study results from different clinical trials to address questions of clinical interest. It is done as a systematic review of the relevant clinical trials. Meta-analysis is usually conducted in three steps: data/study selection, statistical analysis, and interpretation. We discuss the practical issues in these three steps and introduce how a proper meta-analysis is conducted. A case study of meta-analysis of fatal adverse events in cancer patients treated with aflibercept is introduced and its limitations are discussed.

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