2018 年度 医学統計学集中講義シリーズ

2018年度　医学統計学集中講義シリーズ

主催：国立循環器病研究センター・データサイエンス部
共催：京都大学大学院医学研究科・臨床統計学，京都大学大学院医学研究科・医療統計学

 日本医療研究開発機構(AMED)・生物統計家育成支援事業(京都大学×京都大学病院×国立循環器病研究センター)の一環として，下記の要領で医学統計学集中講義を開講します．講師としてNaitee Ting先生を招へいし，2018年10月17日(水)に "Statistical Science in Drug Development”，2018年10月22日(月)に“Phase II Clinical Development of New Drugs”の演題で講義いただきます．前者はEvans SR, Ting N. Fundamental Concepts for New Clinical Trialists. CRC Press, 2015，後者はTing N, Chen DG, Ho S, Cappelleri JC. Phase II Clinical Development of New Drugs. Springer, 2017の内容を主とする講義です．皆様の奮ってのご参加をお待ちしています．

【参考図書】
2018年10月17日(水): Evans SR, Ting N. Fundamental Concepts for New Clinical Trialists. CRC Press, 2015.  https://www.crcpress.com/Fundamental-Concepts-for-New-Clinical-Trialists/Evans-Ting/p/book/9781420090871

2018年10月22日(月): Ting N, Chen DG, Ho S, Cappelleri JC. Phase II Clinical Development of New Drugs. Springer, 2017. https://www.springer.com/us/book/9789811041921

【 申し込み方法】
申し込みは下記のURLから，第1日目と第2日目のそれぞれで受講申し込みをお願いします．定員は35名で，定員に達したところで申し込み受け付けを終了します．参加費は無料です．通訳などの提供はありません．

2018年10月17日(水): https://www.kokuchpro.com/event/ncvcds1810NT/338858/
2018年10月22日(月): https://www.kokuchpro.com/event/ncvcds1810NT/338859/

【 講義スケジュール】
2018年10月17日(水) 午前9時30分～午後5時 (開場 午前9時～)
2018年10月22日(月)  午前9時30分～午後5時 (開場 午前9時～)
1限 午前9時30分～午前11時・2限 午前11時15分～午後12時45分
3限 午後1時45分～午後3時15分・4限 午後3時30分～午後5時

【 場　所 】
千里ライフサイエンスセンタービル8階 802号室
〒560-0082 大阪府豊中市新千里東町1-4-2

【 参加費 】
無料

【  講　師 】
Dr. Naitee Ting (Boehringer-Ingelheim Pharmaceutical)

【 講義要旨】
2018年10月17日(水) 
"Statistical Science in Drug Development"
The 1962 Kefauver Harris Amendment requests the US FDA (Food and Drug Administration) to review the effectiveness and safety of a new drug before the drug can be approved. The scientific foundation of this Amendment is statistical hypothesis testing. Hence one of the most important scientific rational for drug development and drug approval is statistics. This short course introduces clinical trials, drug development process, statistical analysis plan and clinical safety assessment. All of these topics are important components of the statistical science in drug development.

2018年10月22日(月) 
"Phase II Clinical Development of New Drugs"
In the process of medicine discovery and development, understanding the dose-response relationship is one of the most important and challenging tasks. It is critical to identify the right range of doses in early stages of medicine development so that Phase III trials can be properly designed to confirm appropriate dose(s) for the patient. Usually in the beginning of Phase II development, there is limited information to help guide trial designs, therefore Phase II clinical trials often consists of objectives for establishing proof of concept (PoC), identifying a set of potentially safe and efficacious doses, and characterizing the dose-response relationship.

Some of the major challenges in designing these Phase II trials include the selection of dose range and frequency, clinical endpoints and/or biomarkers, and the use of control(s). Inappropriate Phase II trial designs may lead to delay of the medicine development program or waste of investment. Specifically, misleading results from poorly designed Phase II trials could force a Phase III program to confirm sub-optimal dose(s), or even stop developing a potentially useful medicine. Therefore, it is critical to consider Phase II trial designs, in the broader context of the entire medicine development plan, to make the best use of all available information, and to engage relevant experts. This presentation will focus on these perspectiv

【 講師紹介】
Dr. Naitee Ting, Ph.D., is a Fellow of American Statistical Association (ASA).
He is currently a Director in the Department of Biostatistics and Data Sciences at Boehringer-Ingelheim Pharmaceuticals Inc (BI). He joined BI in September of 2009, and before joining BI, he was at Pfizer Inc. for 22 years (1987-2009). Naitee received his Ph.D. in 1987 from Colorado State University (major in Statistics). He has an M.S. degree from Mississippi State University (1979, Statistics) and a B.S. degree from College of Chinese Culture (1976, Forestry) at Taipei, Taiwan.

Dr. Ting published articles in Technometrics, Statistics in Medicine, Drug Information Journal, Journal of Statistical Planning and Inference, Journal of Biopharmaceutical Statistics, Biometrical Journal, Statistics and Probability Letters, and Journal of Statistical Computation and Simulation. His book “Dose Finding in Drug Development” was published in 2006 by Springer, and is considered as the leading reference in
the field of dose response clinical trials. The book “Fundamental Concepts for New Clinical Trialists”, coauthored with Scott Evans, was published by CRC in 2015. Naitee is an adjunct professor of Columbia University, University of Connecticut and University of Rhode Island. Naitee has been an active member of both the ASA and the International Chinese Statistical Association (ICSA).