• 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. 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.