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篇二：实战真章 |
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| Moderator 主持人 | Yajun Xue 薛亚军, Yuxiu Liu 刘玉秀, Wei Li 李卫 | |
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08:30-08:40 |
Opening Remark 开场致辞 |
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08:40-08:50 |
How to Conduct Clinical Trial Design in Medical Devices Cooperating With Statistician 如何跟统计师配合进行医疗器械临床试验设计 |
Bo Xu 徐波 |
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08:50-09:00 |
Clinical Trial of Medical Devices and Regulatory Science 医疗器械临床试验与监管科学 |
Lihong Liu 刘丽宏 |
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09:00-09:10 |
The Importance of Literature Reading and Evaluation for Clinical Trial Design in Medical Devices 文献阅读和评价在医疗器械临床试验设计中的重要性 |
Xiaoyan Yan 阎小妍 |
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09:10-09:20 |
Common Sample size Estimation Method are Used in Clinical Trials of Medical Devices 医疗器械临床试验常用样本量估计方法 |
Xueying Li 李雪迎 |
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09:20-09:30 |
Statistical Considerations for Non-inferiority Study Design 非劣效研究设计的统计学考虑 |
Yanyan Zhao 赵延延 |
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09:30-09:40 |
Statistical Considerations for Single-arm Objective Performance Criteria Trials 单组目标值试验设计的统计学考虑 |
Sidong Li 李思冬 |
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09:40-10:15 |
Discussion 讨论 |
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10:15-10:20 |
Break 休息 |
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第一场 |
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| Moderator 主持人 | Jia He 贺佳, Jing Li 李静, Yang Wang 王杨 | |
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10:20-10:30 |
Design Key points of Quantitative Diagnostic Trials 定量指标诊断试验的设计要点 |
Tao Xu 徐涛 |
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10:30-10:40 |
Design Key points of Qualitative Diagnostic Trials 定性指标诊断试验的设计要点 |
Zhiguang Liu 刘之光 |
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10:40-10:50 |
The Multiplicity Problem caused by Interim Analysis and its Handling Strategy 期中分析所致多重性问题及处理 |
Chuangshi Wang 王闯世 |
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10:50-11:00 |
Common Statistical Methods are Used in Clinical Trials of Medical Devices 医疗器械临床试验常用统计分析方法 |
Xiaoyong Sai 赛晓勇 |
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11:00-11:10 |
Key Elements of Multiple-Imputation (MI) Method Operation for Missing Data 缺失数据多重填补（Multiple-Imputation，MI）方法操作的关键要素 |
Hongqiu Gu 谷鸿秋 |
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11:10-11:20 |
Key Elements of Tipping-Point (TP) Method Operation for Missing Data 缺失数据临界点（Tipping-Point, TP）法操作的关键要素 |
Weida Liu 刘炜达 |
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11:20-12:00 |
Discussion 讨论 |
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