Statistician's Roles in the Center for Drug Evaluation (CDE) of Taiwan

統計學家於CDE扮演的角色

王玫(Mey Wang)；宮玫芳(Mei-Fen Kung)

統計學家 ； 審查員 ； Statistician ； CDE ； INDs ； NDAs ； reviewer

中國統計學報

53卷3期（2015 / 09 / 01）

172 - 185

英文

統計學家於CDE扮演的角色包括擔任統計審查員，負責評估臨床試驗計畫書（INDs）及新藥上市申請案（NDAs）、提供諮詢輔導、制定法規基準、以及從事審查業務以外的教學、學術交流與研究。對於新藥申請上市提交的文件，完整的統計審查包括審閱臨床試驗計畫書、統計分析計畫、以及臨床試驗報告。著重於評估統計相關的試驗設計、統計分析、及試驗結果詮釋的適當性，同時須確認試驗數據的收集無重要缺失，以保證試驗的品質。然而，統計評估亦須與其他領域專家包括臨床、藥學、及化學等審查評估人員合作與互動，並與申請方的統計學家於送件前、送件期間、與送件後，作必要的溝通與聯繫，以提高審查效率。CDE的統計學家不僅須持續吸取最新的統計學知識，亦須時常研究創新的統計方法學以解決困難的法規問題。總結而言，法規單位內有常設的、足夠的統計審查人力，將能完整、全面的執行統計評估，並提供高品質的科學性建議。另外，經由與學術界及業界統計學家的交流與分享，不僅可以達到共識，亦促進統計方法學的創新與進步。

Roles of statisticians in CDE are identified as reviewers in evaluation of clinical trial protocols (INDs) and evaluation of New Drug Applications (NDAs), provision of advisory services, formulation of guidelines, and other off-office activities. Full statistical review of submissions requires assessment of clinical trial protocols, statistical analysis plans, and clinical reports. The statisticians in CDE assess the adequacy of statistical aspects of the study design, analyses and interpretation of the results, and data collection and quality assurance of each study. These assessments should be made in cooperation with clinical, pharmacological, and chemical colleagues; and liaison with company statisticians before, during, and after submission of the application, if the procedure is to be efficient. Apart from having to continually draw on the newest statistical methodology, statisticians in CDE are often called upon for innovative approaches to solve difficult regulatory problems. In summary, the full power of statisticians in regulatory agency will enable comprehensive statistical review and provide high quality scientific advice. Moreover, through interaction with academia and the pharmaceutical industry on current and novel methods, consensus can be reached and innovation be promoted.

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