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1. Introduction
2. Topics covered in this talk
3. Part 1: introduction to flexible trials
4. What are flexible clinical trials
5. Advantages of flexible clinical trials
6. Part 2: group sequential designs
7. Example: the CRASH trial
8. Static single-look design
9. Drawback of the single-look design
10. Group sequential design
11. Tracking the path of the test statistic
12. Logistical aspects of group sequential monitoring
13. Part 3: information based design
14. Information based design of a hepatitis-C trial
15. Uncertainty about sample size
16. A flexible approach to sample size
17. Fixing the information by letting sample size float
18. Interim monitoring of hepatitis-C protocol (1)
19. Interim monitoring of hepatitis-C protocol (2)
20. Logistical aspects of information based designs
21. Part 4: adaptive designs
22. Flexibility of the adaptive methods
23. Example 1: Parkinson's disease treatment trial
24. Example 2: coronary by-pass trial
25. Problem with this sample size specification
26. But when the interim look was taken...
27. Example 3: negative symptoms schizophrenia trial
28. Sample size computation
29. Example 4: oncology trial
30. Unforeseen events can occur
31. Adaptive re-design
32. Part 5: concluding remarks
33. Comments on these examples
34. Open questions for adaptive trials
35. Recapitulate
36. FDA's critical path initiative

Topics Covered

• Advantages of flexible clinical trials
• Group sequential designs
• Information based designs
• Applications and logistical aspects of information based designs
• Adaptive designs
• Flexibility of the adaptive methods
• Sample size computation
• Group sequential or adaptive trial re-design due to the occurrence of unforeseen events
• Flexible trial designs and the FDA's Critical Path Initiative

Links

Series:

• Design and Analysis of Randomized Clinical Trials

Categories:

• Methods
• Pharmaceutical Sciences

Talk Citation

Publication History

• Published on October 1, 2007
• Archived on May 31, 2018

Financial Disclosures

• Dr. Cyrus Mehta has not informed HSTalks of any commercial/financial relationship that it is appropriate to disclose.