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1. Introduction
2. Topics
3. Definition of a clinical trial
4. The great compromise in medical research
5. The nature of research
6. The nature of inference
7. The population can fool us
8. Generalizing to the population
9. Extending to the population
10. The task of the investigators
11. The optimal configuration of the sample
12. Inappropriate use of the sample
13. Trustworthy estimates
14. Other sources of variability
15. Random research
16. Experimental corruption
17. Prospectively designed research
18. Problems caused by random research
19. Patience and tight protocols
20. Different types of endpoints
21. The role and relative number of analyses
22. Community responsibility
23. Investigator mandate
24. Sample versus population
25. P-values should not do your thinking for you
26. Loud messengers
27. Shrine worship
28. P-values
29. Evolution in trial methodology
30. Arguments for multiple endpoints
31. Conflict within the trial's interpretation
32. Collisions
33. Example of type I error inflation
34. Probability of at least one type I error
35. Bonferroni correction
36. Don't ask.....don't tell.. policy
37. Possible scenario
38. Decision is sequence dependent
39. Bitter fruit of don't ask...don't tell
40. Negative primary endpoints
41. Conclusions

Topics Covered

• Definition of a clinical trial
• The great compromise of medical research
• The populations can fool us
• Extending to the population
• Appropriate sampling
• Trustworthy estimates
• Random research
• Experimental corruption
• Prospectively designed research
• Patience and tight protocols
• Endpoints
• Community responsibility
• Investigator mandate
• P-values: pros and cons
• Evolution in trial methodology
• Argument for multiple endpoints
• Conflict within trial interpretation
• Type I error inflation
• Bonferroni correction
• Negative primary endpoints

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

• Prof. Lemuel Moye has not informed HSTalks of any commercial/financial relationship that it is appropriate to disclose.