Post on 25-May-2015
2. Science
3. 4. Scale-up 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 Botanicals with historical documentation of safe human use 5. The Evidence Pyramid 6. Starting from
7. Ask a good (exciting) question
8. How to ask a goog question? ~Fromgooddaily patients care
9. Ask a good question
10. Before study design
11. Clinical Trials Design
12. Case series: Drug A in the treatment of URI
13. Cases series Drug A in the treatment of obesity
14. Uncontrolled studies
15. Uncontrolled studies
16. Gold standard ~ randomized controlled trials 17. Structure of Randomized Control Trials Randomized Endpoints Trial subjects TreatmentControl 18. Trial subjects selection
19. TCM in the treatment of hyperuricemia Patients selection
20. How to find agood intervention for clinical trial?
21. Structure of Randomized Control Trials Randomized Endpoints Trial subjects TreatmentControl 22. Methods of control
23. Bad controls
24. Controlled trial: Drug A and B in the treatment of obesity
25. Controlled trial: Drug A and B in the treatment of obesity
26. Double blind +/- double dummy Randomization Endpoints Trial subjects A "Placebo or B 27. Randomization
28. Randomization
29. Endpoints
30. Blind Method
31. Crossover Clinical Trial Drug B Drug A W A S HO U T Phase 1 Period Eligible Patients /subjects Drug A Drug B Informed consent Drug B Drug A Phase 2 32.
33. Adaptive designs
34. Protocol
35. Research team & Resources
36. Chung Shan Medical University Hospital Chinese Medicine Clinical Trial Center GCRC(General Clinical Research Center)
SMO(site-management organization) GCRC(General Clinical Research Center) CMCTCChinese Medicine Clinical Trial Center Administrative 2 assistants Clinical affairs 1 CRA/HN 4 CRC Data management 1 Statistic PhD 2 Statistic MS 2 MD1 Pharmacist 20 Consultants 37.
38. Contact us: CSMUH Chinese Medicine Clinical Trial Center http://www.csh.org.tw/into/herb James Cheng-Chung Wei, MD, PhD ( )[email_address]