臨床試驗研究設計與實務
Research design and practical issues on clinical trial
| 節 | 週四 |
|---|---|
7 15:30–16:20 | 臨床試驗研究設計與實務 YS221 2 節連堂 |
8 16:30–17:20 |
* 根據陽明交大上課時間表所列
本課程希望讓同學瞭解臨床試驗研究設計與實務相關議題,以因應日益蓬勃之臨床試驗市場需求。 將介紹臨床試驗研究設計與實務相關議題,包括:臨床試驗簡介、臨床試驗設計、臨床試驗統計分析、臨床試驗相關法規及倫理議題、臨床試驗計畫書、臨床試驗執行及監測、臨床試驗查核、臨床試驗之查驗登記等相關議題。
修過生物統計學及流行病學者優先
課堂實體授課
課堂參與 20% 期中考 30% 期末課堂報告25% 期末書面報告25%
| 週次 | 主題 |
|---|---|
| 第 1 週 | Introduction to clinical trial |
| 第 2 週 | Design in clinical trial I |
| 第 3 週 | Design in clinical trial II |
| 第 4 週 | Design in clinical trial III |
| 第 5 週 | Design in clinical trial IV |
| 第 6 週 | Statistical analysis plan in clinical trial I |
| 第 7 週 | Statistical analysis plan in clinical trial II |
| 第 8 週 | Mid-term examination |
| 第 9 週 | Ethical issues in clinical trial |
| 第 10 週 | 臨床試驗與執行 (醫藥品查驗中心吳柏立專門委員) |
| 第 11 週 | Clinical trial GCP inspection (台塑生醫科技股份有限公司醫藥發展處鄭佩婷副理) |
| 第 12 週 | Legal and Regulation issues in clinical trial 臨床試驗相關法規議題(林志六醫師/律師) |
| 第 13 週 | Conduct clinical trial – the role of CRO and clinical monitoring (百瑞精鼎 黃秀萱資深總監) |
| 第 14 週 | Clinical Trial Enrollment - from protocol design to clinical operation (台灣第一三共仇琍茵部長) |
| 第 15 週 | Final report |
| 第 16 週 | Final examination |
1. Friedman LM, Furberg CD, DeMets SL. Fundamental of Clinical Trials. Springer, 1998. 2. International Council for Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) 3. ICH guideline E8 (R1) on general considerations for clinical studies 4. ICH Topic E 9 Statistical Principles for Clinical Trials 5. ICH Topic E 10 Choice of Control Group in Clinical Trials 6. ICH E9 (R1) addendum on estimands and sensitivity analysis in clinical trials to the guideline on statistical principles for clinical trials 7. E6(R2) Good Clinical Practice: Integrated Addendum to ICH E6(R1) 8. FDA Adaptive Designs for Clinical Trials of Drugs and Biologics 9. FDA Oversight of Clinical Investigations — A Risk-Based Approach to Monitoring 10. FDA Inspections of Clinical Investigators 11. E17 General Principles for Planning and Design of Multiregional Clinical Trials 12. Gamble C, Krishan A, Stocken D, Lewis S, Juszczak E, Doré C, Williamson PR, Altman DG, Montgomery A, Lim P, Berlin J, Senn S, Day S, Barbachano Y, Loder E. Guidelines for the Content of Statistical Analysis Plans in Clinical Trials. JAMA. 2017 Dec 19;318(23):2337-2343. doi: 10.1001/jama.2017.18556. PMID: 29260229. 13. Velentgas P, Dreyer NA, Nourjah P, Smith SR, Torchia MM, eds. Developing a Protocol for 444 Observational Comparative Effectiveness Research: A User’s Guide. AHRQ Publication No. 12(13)-445 EHC099. Rockville, MD: Agency for Healthcare Research and Quality; January 2013. 446 www.effectivehealthcare.ahrq.gov/Methods-OCER.cfm. (Chapt 6) 14. 藥品優良臨床試驗作業指引,衛生福利部 中華民國 109 年 9 月。
- 地點
- 醫學二館212室
- 時間
- 週四上午11:00~12:00
- 聯絡方式
- mingweilin@nycu.edu.tw