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2013/5/17-19
Clinical Trial Protocol Writing Workshop II

Overview of Scientific Principles & Underpinning Concept Development (2013/5/17) Dr. Chee Khoon Lee
Study designs and trials (2013/5/18) Prof. Val Gebski and Dr. Chee Khoon Lee

Measures of Effect & Statistical Considerations (2013/5/19)

Prof. Val Gebski

2013/1/18-21 Clinical Protocol Writing Workshop

Subject
Speaker
Video
Independent Data Safety &
Monitoring Committees & Early Stopping of Trials
1. Why IDSMBs (Prof. Val Gebski)
2. Establishing-Chairing an IDSMB
(Dr. Simon Ruey-Kuen Hsieh)
3. IDSMBs Terms of Reference
(Prof. Val Gebski)
4. Emerging evidence (Prof. Val Gebski)
5 The IDSMC process
(Prof. James Chih-Hsin Yang)
6. Statistical Methods for stopping rules
(Dr. Chee Khoon Lee)
7. Assessing futility
(Dr. Chee Khoon Lee)
8. Process for stopping a trial
(Prof. Chee-Jen Chang)
9. Multiple IDSMCs FINAL
(Dr. Chee Khoon Lee)
Concept Development 1. Principles involved in concept development (Dr. Chee Khoon Lee)
2. Study design
(Dr. Chee Khoon Lee)
3. Outcomes and Endpoints
(Dr. Chee Khoon Lee)
4. Sample Size
(Prof. Val Gebski)
5. Interim Monitoring
(Prof. Val Gebski)
6. Feasibility & Study Procedures
(Prof. Val Gebski)
Elements/Principles of Meta Analyses 1. Basic Principles of Meta-Analysis (Dr. Chee Khoon Lee)
2. Selection of Studies for Meta-analysis
(Dr. Chee Khoon Lee)
3. Combining Effects
(Dr. Chee Khoon Lee)
4. Toxicities Meta-Analysis
(Dr. Chee Khoon Lee)
5. Trial Quality
(Prof. Val Gebski)
6. Interpreting results
(Prof. Val Gebski)
7. Estimating Publication Bias (Prof. Val Gebski)
8. Network Meta-analysis
(Dr. Yu-Kang Tu)

2012/2/4.5
First Japan Taiwan Oncology Phase I Trial Conference (JTOPIC)

Oncology Phase I Trials in Japan - Past, Present, and Future Dr. Nagahiro Saijo 西條長宏
Kinki University Hospital,
Osaka, Japan
Oncology Phase I Trials at the National Taiwan University Hospital 林家齊醫師
台大醫院腫瘤醫學部
早期臨床試驗中心 主任
Regulator’s Perspectives on Multinational Oncology Phase I Studies 陳恆德醫師
財團法人醫藥品查驗中心執行長

2011/12/18
Symposium on“New Approaches and Perspectives in Molecularly Targeted and Biomarker Trials”

Prognostic Biomarkers and Adaptive Designs in Early Phase Clinical Trials: Efficiency Myth and a Case Study 張應權博士
Dr. Ying Kuen Kenneth Cheung
Columbia University
Molecular Gene Signatures and Cancer Clinical Trials 丁美齡博士
Dr. Mei-Ling Ting Lee
University of Maryland
     

2011/6/25
台大醫院人體試驗研討會-100年臨床試驗課程(Courses for Clinical trials)

試驗用藥管理
台大醫院藥劑部管理組 周華藥師

2011/9/24
台大醫院人體試驗研討會-100年臨床試驗進階課程(Advanced Courses for Clinical trials)

受試者參與試驗 自願剝削或脅迫
台大醫院 吳建昌醫師

2011/11/5
台大醫院人體試驗研討會-100年臨床試驗應用課程(Practical Courses for Clinical trials)

計畫書的遵從(含計畫書的設計與導讀)
林家齊醫師
台大醫院腫瘤醫學部
早期臨床試驗中心 主任
檢體運送與管理
愛康研究有限公司 資深臨床研究專員
甘小萍小姐

Taiwan Clinical Trial Statistical Center, Training Center, and Pharmacogenomics Laboratory

Building of College of Public Health, National Taiwan University
Room 808, No.17, Xu-Zhou Road, Taipei City 100, Taiwan
TEL : 02-3366-8657 FAX : 02-3366-8608

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