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臨床試驗設計 ~ 常見問題與分析  魏正宗 醫師  James Cheng-Chung WEI, MD, PhD 中山醫學大學附設醫院 過敏免疫風濕科主任 、 中藥臨床試驗中心主任 人體試驗委員會前主任委員
 
The Evidence Pyramid
臨床研究  How to Start? ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Ask a good (exciting) question  before designing a clinical trial ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
How to ask a goog question? ~From  good  daily patients care ,[object Object],[object Object],[object Object],[object Object],[object Object]
Clinical Trials Design ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Uncontrolled studies ,[object Object],[object Object],[object Object],[object Object],[object Object]
 
 
Defects of Uncontrolled studies ,[object Object],[object Object],[object Object],[object Object]
臨床試驗設計的 Gold standard ~  隨機對照試驗   ( randomized controlled trials )
Structure of Randomized Control Trials Randomized Endpoints Trial subjects Treatment  Control
Indications selection ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Trial subjects selection ,[object Object],[object Object],[object Object],[object Object],[object Object]
How to find a  good intervention for clinical trial? ,[object Object],[object Object],[object Object],[object Object]
Structure of Randomized Control Trials Randomized Endpoints Trial subjects Treatment  Control
Methods of control ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
“Bad” controls ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Add-on therapy design ,[object Object],[object Object],[object Object],[object Object],[object Object]
Controlled trial: Drug A and B in the treatment of obesity ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Double blind +/- double dummy Randomization Endpoints Trial subjects “ A” "Placebo” or “B”
隨機化   Randomization ,[object Object],[object Object],[object Object]
Randomization ,[object Object],[object Object],[object Object]
Endpoints ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
盲法( Blind Method ) ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
雙虛擬設計 (double-blind, double-dummy) ,[object Object]
Crossover Clinical Trial Drug B Drug A W A S H  O U T Phase 1 Period Eligible Patients /subjects Drug A Drug B Informed consent Drug B Drug A Phase 2
平行設計與交叉設計  ,[object Object],[object Object]
Adaptive designs ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Sample size estimation ,[object Object],[object Object],[object Object],[object Object],[object Object]
樣本數之估算 ,[object Object],[object Object],[object Object]
資料分析  ITT vs PP ,[object Object],[object Object]
臨床試驗計畫書 Protocol ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Research team & Resources ,[object Object],[object Object],[object Object]
Chung Shan Medical University Hospital   Chinese Medicine Clinical Trial Center GCRC  (General Clinical Research Center) ,[object Object],SMO  (site-management organization)   GCRC  (General Clinical Research Center) CMCTC  Chinese Medicine Clinical Trial Center Administrative 2 assistants Clinical affairs 1 CRA/HN 4 CRC   Data management 1 Statistic PhD 2 Statistic MS 2 MD  1 Pharmacist 20 Consultants
臨床研究的執行 ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
中山醫學大學附設醫院 中藥臨床試驗中心 研究重點 ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Contact us:   CSMUH Chinese Medicine Clinical Trial Center   http://www.csh.org.tw/into/herb   James Cheng-Chung Wei, MD, PhD ( 魏正宗 )  [email_address]

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臨床試驗設計的常見問題與分析

  • 1. 臨床試驗設計 ~ 常見問題與分析 魏正宗 醫師 James Cheng-Chung WEI, MD, PhD 中山醫學大學附設醫院 過敏免疫風濕科主任 、 中藥臨床試驗中心主任 人體試驗委員會前主任委員
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  • 12. 臨床試驗設計的 Gold standard ~ 隨機對照試驗 ( randomized controlled trials )
  • 13. Structure of Randomized Control Trials Randomized Endpoints Trial subjects Treatment Control
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  • 17. Structure of Randomized Control Trials Randomized Endpoints Trial subjects Treatment Control
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  • 22. Double blind +/- double dummy Randomization Endpoints Trial subjects “ A” "Placebo” or “B”
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  • 28. Crossover Clinical Trial Drug B Drug A W A S H O U T Phase 1 Period Eligible Patients /subjects Drug A Drug B Informed consent Drug B Drug A Phase 2
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  • 39. Contact us: CSMUH Chinese Medicine Clinical Trial Center http://www.csh.org.tw/into/herb James Cheng-Chung Wei, MD, PhD ( 魏正宗 ) [email_address]