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

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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