中醫藥臨床試驗設計[1]

中醫藥臨床試驗設計與執行 ~ 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

Integrative Medicine ,[object Object],[object Object],[object Object],[object Object],[object Object]

新藥開發流程 Scale-up 臨床前研究臨床試驗新藥審核 12-24 months 1-4 month 9-12 months 12-24 months 6-18 months Phase II Phase IV Pharmacology and Pharmacokinetics Animal Safety Testing Submit IND Submit NDA NDA Approval Formulation Chemistry and Physical Characterization Phase III 新藥監視 Botanicals with historical documentation of safe human use

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]

選病 Trial subjects selection ,[object Object],[object Object],[object Object],[object Object],[object Object]

Botanical Applications in FDA (as of December 31, 2007)

選方 Trial intervention ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]

How to find a good TCM intervention for clinical trial? ,[object Object],[object Object],[object Object],[object Object]

中草藥新藥臨床試驗 (IND) 申請須知 ,[object Object],[object Object],[object Object],[object Object],[object Object]

Basic Principles in the FDA Botanical Guidance ,[object Object],[object Object],[object Object],[object Object],[object Object]

Evidence of prior/current uses ,[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]

Study design: RCT Active group,36 week -4 0 4 8 12 screening randomization end of trial Inactive group, 24 中藥方劑治療僵直性脊椎炎之先導性臨床試驗 A （ NSAID ） B （ Sulfasalazine ） C （小活絡丹） D （龜鹿二仙膠） E （左歸丸）

中藥方劑治療僵直性脊椎炎之先導性臨床試驗 Results ,[object Object],[object Object],[object Object],[object Object]

Dose ranging Phase II/III trial design Meet all criteria Randomization (~ 588 patients) 20% 40% 40% ~ 196 patients ~ 392 patients

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]

臨床研究的執行 ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]

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/manager 4 CRC Data management 1 Statistic PhD 2 Statistic MS 2 MD 1 Pharmacist 20 Consultants

臨床試驗管理中心 ,[object Object],[object Object],[object Object],[object Object],[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]

中醫藥臨床研究發展方向 ,[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]

中醫藥臨床試驗設計[1]

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中醫藥臨床試驗設計[1]

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