2018 年度 医学統計学集中講義(第1回)

2018年度　医学統計学集中講義

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：京都大学医学研究科・臨床統計学，京都大学医学研究科・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Frank Bretz先生を招へいし，第1日目は “Multiplicity in Clinical Trials”，第2日目は “Adaptive Deigns in Clinical Trials”の内容で講義いただきます．

 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．同時通訳の提供はありません．皆様の奮ってのご参加をお待ちしています．

【 申し込みURL】
第1日目  http://www.kokuchpro.com/event/ncvcds1805FB/240768/
第2日目  http://www.kokuchpro.com/event/ncvcds1805FB/240770/

【 日　時 】
第1日目 2018年5月31日(木) 午前9時30分～午後5時 (開場 午前9時～)
第2日目 2018年6月1日(金)  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 】
大阪市北区梅田2-4-9　ブリーゼタワー8階
第1日目 会議室801/802・第2日目 会議室803/804
※1日目と2日目で会場が異なります．ご注意ください．

【 参加費 】
無料

【  講　師 】
Professor Dr. Frank Bretz (Novartis AG)

【 講義要旨】
The issue of multiplicity often arises in the design and analysis of clinical trials. Common multiple test problems include comparing several treatments with a control, assessing the benefit of a new treatment for more than one endpoint, combined non-inferiority and superiority testing, or any combination thereof. One particular application arises in confirmatory adaptive design trials, when multiplicity adjustments are mandatory to account for adaptations made during the study. This two-day course will begin with the introduction of the basic fundamentals of multiplicity methodology, and continue through novel methods and strategies for addressing multiplicity concerns. These techniques will be demonstrated with several case studies. The sessions of each morning target at a broader drug development audience at are accessible to non-statisticians as well.

 Day-1: In the morning of Day 1 we will consider sources and impact of multiplicity in clinical trials and continue with special considerations, such handling multiple endpoints and multiple doses. In the afternoon, we review key concepts in multiple testing and introduce graphical approaches.

 Day-2: In the morning of Day 2 we will introduce confirmatory adaptive designs and review several case studies, including interactions with regulatory agencies. In the afternoon we dwell into technical details, including causes of multiplicity and bias in adaptive designs, repeated hypothesis testing in group sequential designs, and multiple hypotheses testing in adaptive designs. We review principles of adaptive testing procedures, including the combination test principle and the conditional error principle. We demonstrate these techniques in with case studies for treatment selection in two-stage adaptive designs.

Professor Dr. Frank Bretz joined Novartis in 2004, where he is currently Global Head of the Statistical Methodology and Consulting group. He has supported the methodological development in various areas of drug development, including dose finding, multiple comparisons, and adaptive designs. Frank is currently holding Adjunct/Guest professorial positions at the Hannover Medical School (Germany), Shanghai University of Finance and Economics (P.R. China), Medical University of Vienna (Austria) and Osaka University (Japan). 

His primary research interests include multiple comparison procedures, dose response experiments and adaptive designs. These topics are frequently encountered in practice and have applications in such different areas as clinical trials, toxicology, biology, physics, etc. In the past he was also interested in multidimensional integration routines to compute probabilities and critical values from multivariate distribution functions as well as in the design and analysis of microarray experiments. Among other professional services, he is a co-founding editor of the Springer Series in Pharmaceutical Statistics and the editor-in-chief of Statistics in Biopharmaceutical Research. He has authored or co-authored more than 130 articles in peer-reviewed journals and four books. Frank is a Novartis Distinguished Scientist, a recipient of the Susanne-Dahms-Medal from the German Region of the International Biometric Society and a Fellow of the American Statistical Association.