The 9th Clinical Research Workshop Part I
第九届临床研究专题研讨峰会第一部分

8:30 AM-12:00 PM Thursday, March 30, 2017

2017年03月30日 星期四   8:30 AM-12:00 PM

Function Hall A, Level 1

一层多功能A厅

  Session I: Road to Excellence in Clinical Research - How to Become a Premier Research Center
第一场：临床研究卓越之路 - 怎样成为一流研究中心
Moderator 主持人 Alexandra J. Lansky, Shaoliang Chen 陈绍良
Discussant 讨论者 Priyadarshini Arambam, Yaling Han 韩雅玲, Ajay J. Kirtane, Mitchell W. Krucoff, Wei Li 李卫, Marie-Angèle Morel, Jenny Zhen Qin, Xinli Shi 史新立

8:30 AM-

Introduction and Objectives
目的简介		 Roxana Mehran

8:33 AM-

Welcome Address
欢迎致辞		 Runlin Gao 高润霖

8:35 AM-

How to Start and Set up a Thriving Clinical Research Program and Be a Key Enroller: The Basics and Balance
怎样开始和设立一个蓬勃发展的临床研究项目及成为一个关键的入选者：基本要素和平衡考量		 Yaling Han 韩雅玲

8:45 AM-

Guiding Principles in Clinical Research: The Cardinal Rules (GCP, IRB, Informed Consent, Quality Assurance)
临床研究的指导原则：基本规则（GCP、IRB、知情同意及质控）		 Alexandra J. Lansky

8:55 AM-

The Future of Global Collaboration in Medical Device Research: The Role of Structured Data and Minimum Core Data Sets
医疗器械研究全球合作的未来：结构化数据和最小核心数据集的作用		 Mitchell W. Krucoff

9:05 AM-

Statistical Considerations of Clinical Trial Design for Innovative Medical Device
创新心血管器械临床试验设计的统计学考虑		 Wei Li 李卫

9:20 AM-

Statistical Considerations of Subgroup Analysis, Composite Endpoints, Surrogate Endpoints, and Others
亚组分析、复合终点、替代终点及其他的统计学考虑		 Ajay J. Kirtane

9:30 AM-

Featured Lecture: Challenges and Solutions of Conducting Large-Scale Clinical Trial in China
特色演讲：在中国实施大规模临床试验的挑战和解决方案		 Lixin Jiang 蒋立新

9:45 AM-

Panel Discussion with Audience Q&A
专家讨论及听众问答
  Session II: Clinical Trials and Observational Studies - Lessons Learned from the Literature
第二场：临床试验和观察性研究 - 来自文献的经验
Moderator 主持人 Roxana Mehran, Yaling Han 韩雅玲
Discussant 讨论者 Feng Cao 曹丰, Lixin Jiang 蒋立新, Ajay J. Kirtane, Wei Li 李卫, Gary S. Mintz, Tullio Palmerini, Yang Wang 王杨

10:00 AM-

How Much Can We Trust Randomized Trials: The Good, the Bad, and the Ugly (with case examples)
我们可以信任随机试验到什么程度：好的、坏的及丑陋的（含范例）		 Roxana Mehran

10:12 AM-

Q&A
问答

10:15 AM-

How Much Can We Trust Observational Registries: The Good, the Bad, and the Ugly (with case examples)
我们可以信任观察性登记研究到什么程度：好的、坏的及丑陋的（含范例）		 Ajay J. Kirtane

10:27 AM-

Q&A
问答

10:30 AM-

How Much Can We Trust Meta-Analyses: The Good, the Bad, and the Ugly (with case examples)
我们可以信任荟萃分析到什么程度：好的、坏的及丑陋的（含范例）		 Tullio Palmerini

10:42 AM-

Q&A
问答

10:45 AM-

Panel Discussion
专家讨论
  Session III: Clinical Trial Interpretation - Strengths and Weaknesses of Controversial Interventional Trials of the Last Year
第三场：临床试验解读 - 上一年度发表的争议性介入试验的长处与欠缺
Moderator 主持人 Ajay J. Kirtane, Roxana Mehran
Discussant 讨论者 Robert A. Byrne, Davide Capodanno, Shaoliang Chen 陈绍良, Justin E. Davies, Lixin Jiang 蒋立新, Alexandra J. Lansky, Patrick W. Serruys, Gregg W. Stone

11:00 AM-

ABSORB Data Updates
ABSORB数据更新		 Robert A. Byrne

11:08 AM-

Panel Discussion: Criticisms and Strengths - Impact on Clinical Practice
专家讨论：点评优缺点及其对临床实践的影响

11:20 AM-

EXCEL and NOBLE
EXCEL和NOBLE试验		 Davide Capodanno

11:28 AM-

Panel Discussion: Criticisms and Strengths - Impact on Clinical Practice
专家讨论：点评优缺点及其对临床实践的影响

11:40 AM-

PIONEER AF-PCI and the Future Trials
PIONEER AF-PCI及未来试验		 Roxana Mehran

11:48 AM-

Panel Discussion: Criticisms and Strengths - Impact on Clinical Practice
专家讨论：点评优缺点及其对临床实践的影响

12:00 PM-

Adjourn
休会