时间：Monday, April 22, 2019, 01:30 PM -- 05:00 PM（2019年4月22日，星期一，下午1:30—5:00）
地点：Auditorium Building 1, Novartis Campus No. 4218 Jinke Road, Shanghai（金科路 4218号，诺华上海园区，一号楼大礼堂）
主题：Futility Analyses in Confirmatory Clinical Trials – Methods and Procedures
主讲人：
Paul Gallo, Senior Biometrical Fellow, Statistical Methodology and Consulting, Novartis, US
摘要：
Futility analyses are increasingly utilized in clinical trials. These generally involve interim evaluation of a trial’s primary hypothesis to determine if trial success or clinically meaningful effect seems unlikely. Futility analyses can improve resource efficiency by halting trials with ineffective interventions. They also offer ethical advantages by exposing fewer trial participants to ineffective and possibly toxic interventions, and public health advantages in that trial results may be conveyed to the medical community in a more timely fashion. We will describe what futility analyses are, why they are conducted, where and when they should be considered, and how they should be methodologically and operationally implemented. These analyses should be carefully planned during trial design phase, as there are important statistical and operational implications. Challenging questions arise during trial design regarding how futility analyses should be conducted, the statistical scales on which criteria may be expressed, when futility should be assessed, the role of Data Monitoring Committees, and thresholds at which futility may be established. Non-constancy of effect size and other limitations of accruing interim data can raise further challenges. We will describe current practices and recent advancements in methodological approaches of futility analyses with case studies.
主讲人简介：
Paul Gallo is a Senior Biometrical Fellow and a member of the Statistical Methodology Group at Novartis Pharmaceuticals in East Hanover, NJ. He received a Ph.D. in Statistics from the University of North Carolina in 1982. A main activity at Novartis has involved support of Data Monitoring Committees; he has worked closely with DMCs in many key Novartis trials, and authored company process documents and guidelines governing interim analysis procedures. He has been highly active in industry initiatives relating to adaptive trials, with particular focus on interim monitoring and DMC process issues. He was lead author of the PhRMA Adaptive Designs Working Group’s Executive Summary in Journal of Biopharmaceutical Statistics, and coordinated the production and publication of the group’s full White Paper in Drug Information Journal. He has also played a leading role in industry initiatives relating to multi-regional clinical trials, and analysis issues for multicenter clinical trials. He has been a presenter or responder on behalf of Novartis at 7 FDA Advisory Committee hearings.
He is a Fellow of the American Statistical Association (he also served on the ASA Committee on Fellows, 2016-2018, and was Chair in 2018), and in 2003 received the Novartis VIVA Award, as a Novartis Leading Scientist (officially described in company documentation as “the highest award each Novartis division grants for extraordinary scientific achievements in Research & Development”). He is the author or co-author of 68 publications, and has given presentations, presented short courses, or served as a discussion panelist at scientific conferences on over 90 occasions.
议程：
*会议注册报名及交通说明见附件：
ShanghaiBiostatisticsForum_SpecialEvent_22Apr2019_Novartis Campus_final.pdf