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1. Introduction
2. Presentation outline
3. Why multiple or composite efficacy endpoints?
4. Sources of multiplicity in clinical trials
5. Monte-Carlo estimates of type I error rate inflation
6. Ideal situation - confirmation trials
7. Single endpoint may not be possible/preferred (1)
8. Single endpoint may not be possible/preferred (2)
9. Single endpoint may not be possible/preferred (3)
10. Multiple endpoints in selected disease areas
11. Composite endpoint types - catagorical
12. Composite endpoint types - continuous
13. Motivations for use of composite endpoints
14. Decision-making scenarios under multiplicity
15. Decision-making scenarios (i) ...
16. Example: alfuzosin in BPH
17. Power loss for wining in all K endpoints
18. Sample size multiplier - 80% overall power
19. Decision-making scenarios (ii) ...
20. Example: rimonabant in obese diabetics
21. Decision-making scenarios (iii) ...
22. Decision-making scenarios (iv) ...
23. Example: xaliproden in ALS
24. Why different methods for addressing multiplicity?
25. Decision-making scenarios - composite endpoint
26. Examples of CE in allergic hinitis
27. Holm step-down procedure
28. Hochberg step-up procedure
29. Example 1 - Bonferroni modified procedures
30. Example 2 - Bonferroni modified procedures
31. Example 3 - Bonferroni modified procedures
32. Two-stage statistical tests conclusions
33. Two-stage testing 3 methods
34. Complete closure for 4 endpoints
35. Properties of global tests - power performance
36. Properties of global tests - 7 test statistics
37. 5 power performance tests
38. Simulated adjusted nominal levels
39. Well-known properties of global tests
40. Global test formulas
41. Critical Zalpha/2 values for K correlated endpoints
42. Conclusions
43. Additional references

Topics Covered

• The complexities of a clinical trial with multiple objectives and/or therapeutic areas where the disease manifests itself in a multi-faceted manner
• Reasons for and the common sources of multiplicity in clinical trials
• The associated clinical and statistical approaches for controlling the probability of incorrectly declaring a treatment benefit

Links

Series:

• Design and Analysis of Randomized Clinical Trials

Categories:

• Methods
• Pharmaceutical Sciences

Talk Citation

Sankoh, A. (2007, October 1). Handling multiplicity due to multiple primary or composite endpoints in clinical trials [Video file]. In The Biomedical & Life Sciences Collection, Henry Stewart Talks. Retrieved April 29, 2024, from https://hstalks.com/bs/547/.
Export Citation (RIS)

Publication History

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

Financial Disclosures

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