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Navigable Slide Index

1. Introduction
2. Outline of presentation
3. You feel lost
4. Clinical trials
5. Jargon
6. Equivalence trials
7. Motivation behind equivalence (1)
8. Motivation behind equivalence (2)
9. Active control trials
10. Non-inferiority trials (one-sided equivalence)
11. Choice of trial design
12. Choice of active control [ICH E9]
13. Scematic representation for choice of design
14. Trial design: steps 1 and 2
15. Trial design: step 3
16. Decision of balance
17. Who is the decision maker?
18. Define the difference (1)
19. Choice of delta
20. Define the difference (2)
21. Define the difference (3)
22. Trial design: step 5
23. Factors reducing assay sensitivity
24. Assay sensitivity: assumptions
25. Is a placebo necessary to prove assay sensitivity?
26. Analysis stage: step 5
27. Confidence intervals
28. Hypothesis testing (1)
29. Hypothesis testing (2)
30. Hypothesis testing (3)
31. Hypothesis testing for non-inferiority
32. Interpretation
33. Nominal levels
34. Analysis population (1)
35. Analysis population (2)
36. Analysis population (3)
37. Superiority - non-inferiority (1)
38. Superiority - non-inferiority (2)
39. Illustrative example
40. Two types of colonoscopy detecting colon polyps
41. Colon polyps
42. Appropriate control arm: step 1
43. Superiority or equivalence: step 2
44. Primary objective: step 2
45. Defining delta: step 3
46. Testing approach
47. Assay sensitivity
48. Summary
49. Related guidances
50. References (1)
51. References (2)
52. Hopefully, you are not here anymore
53. Thank you

Topics Covered

• Equivalence trial study design
• Selection of an acceptable margin of equivalence/non-inferiority
• Selection of the control (placebo/active/both)
• Confidence interval or hypothesis testing
• Approach
• Analysis population
• Trial conduct

Links

Series:

• Design and Analysis of Randomized Clinical Trials

Categories:

• Methods
• Pharmaceutical Sciences

Talk Citation

Durkalski-Mauldin, V. (2007, October 1). Design and conduct of equivalence trials [Video file]. In The Biomedical & Life Sciences Collection, Henry Stewart Talks. Retrieved April 18, 2024, from https://hstalks.com/bs/546/.
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Publication History

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

Financial Disclosures

• Prof. Valerie Durkalski-Mauldin has not informed HSTalks of any commercial/financial relationship that it is appropriate to disclose.