臨床試驗設計的常見問題與分析

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

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]

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]

臨床試驗設計的常見問題與分析

Recommended

Recommended

More Related Content

What's hot

What's hot (20)

Viewers also liked

Viewers also liked (7)

Similar to 臨床試驗設計的常見問題與分析

Similar to 臨床試驗設計的常見問題與分析 (20)

More from netnk

More from netnk (13)

Recently uploaded

Recently uploaded (6)

臨床試驗設計的常見問題與分析