时间:2016年1月7日(周四)下午3:00-4:30
地点:闵行校区统计楼105室
报告人:Dr Shiyun Shen, Sr. Director, Global Medical Affairs, Novartis Pharma.
题目:Recurrent Cardiovascular Events with the Presence of Terminal Events as a Primary Endpoint in Advanced Heart Failure Clinical Trials
内容:
1)Recurrent CV related and terminal events
2)Composite endpoints and time-to-first event analysis
3)Relationship between recurrent and terminal events
4)Recurrent events analysis
5)Study design and sample size by using recurrent events
6)Considerations and Conclusions
题目:Plan and Implementation of Adaptive Design in Clinical Development
内容:
1)Type of Adaptations
2)Efficiency of Adaptive Design
3)Technical Concerns
4)Plan and Implementation of Adaptive Design
5)Interactions with Agencies- FDA/EMA
6)Case Studies
7)Summary