• Design
• 34 min
  1. An introduction to randomization for clinical trials 1

  • Prof. William Rosenberger
• 20 min
  2. An introduction to randomization for clinical trials 2

  • Prof. William Rosenberger
• 42 min
  3. Randomisation, blinding and drug supply in interactive voice response trials

  • Mr. Damian McEntegart
• 42 min
  4. Randomization in clinical trials: time for fresh consideration?

  • Dr. Alex Sverdlov
• Analysis
• 32 min
  5. Design and conduct of non-inferiority trials

  • Prof. Valerie Durkalski-Mauldin
• 37 min
  6. Nonparametric covariate adjustment

  • Prof. Michael Akritas
• 34 min
  7. The impact of randomization on the evidence of a clinical trial

  • Prof. Nicole Heussen
• Theory
• 43 min
  8. Historical and ethical issues in trial design

  • Dr. J. Rosser Matthews
• 52 min
  9. Likelihood ratios and the strength of statistical evidence

  • Prof. Jeffrey Blume
• 36 min
  10. Biomarkers and surrogate endpoints in randomized clinical trials

  • Dr. Marc Buyse
• Randomization, Masking and Allocation Concealment
• 22 min
  11. Detection of and adjustment for selection bias in randomized controlled clinical trials

  • Prof. Lieven Nils Kennes
• 46 min
  12. Innovative and effective subject randomization methods

  • Prof. Wenle Zhao
• 12 min
  13. Selection bias in studies with unequal allocation

  • Dr. Olga M. Kuznetsova
• Archived Lectures *These may not cover the latest advances in the field
• 45 min
  14. Design and conduct of equivalence trials

  • Prof. Valerie Durkalski-Mauldin
• 19 min
  15. Dose-finding trials in oncology

  • Prof. Anastasia Ivanova
• 32 min
  16. Allocation concealment, prediction and selection bias

  • Prof. David Torgerson
• 41 min
  17. Pseudo cluster randomization

  • Dr. George Borm
• 26 min
  18. Introduction to flexible, adaptive trial design

  • Dr. Cyrus Mehta
• 30 min
  19. Randomization in clinical trials

  • Prof. William Rosenberger
• 35 min
  20. Novel methods for randomizing

  • Dr. William Grant
• 20 min
  21. Permutation tests

  • Dr. YanYan Zhou
• 59 min
  22. Handling multiplicity due to multiple primary or composite endpoints in clinical trials

  • Dr. Abdul Sankoh
• 32 min
  23. Multiple analyses in clinical trials

  • Prof. Lemuel Moye
• 26 min
  24. Handling of missing data in clinical trials

  • Dr. Linda Yau
• 35 min
  25. A note on the application of post-randomization adjustment

  • Dr. Xun Chen
• 24 min
  26. N-of-1 randomized clinical trials

  • Prof. Patrick Onghena

Printable Handouts

PDF

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

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.