• 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. Dose-finding in oncology
3. Dose lmiting toxicity (DLT)
4. The maximum tolerable dose (MTD)
5. Dose-toxicity relationship
6. Starting dose and dose level selection
7. Traditional or 3+3 design (1)
8. Traditional or 3+3 design (2)
9. Operating characteristics of 3+3 design
10. Advantages and disadvantages of the 3+3 design
11. A+B designs
12. A+B designs: definition
13. A+B designs: how to construct
14. A+B designs: examples
15. Trials with the MTD defined using toxicity grades
16. Defining MTD using toxicity grades: example (1)
17. Defining MTD using toxicity grades: example (2)
18. Defining MTD using toxicity grades: example (3)
19. A summary
20. Escalation vs. fixed sample size designs for trials
21. Fixed sample size vs. A+B designs: which to use?
22. Fixed sample size designs
23. Continual reassessment method (CRM)
24. Cumulative cohort design (CCD) to find the MTD
25. Components of the CRM and CCD
26. Start-up rule (1)
27. Start-up rule (2)
28. Estimation of MTD after cumulative cohort design
29. Design modifications for delayed toxicity outcomes
30. Oncology trial with delayed toxicity outcomes (1)
31. Oncology trial with delayed toxicity outcomes (2)
32. Oncology trial with delayed toxicity outcomes (3)
33. An example of a phase I trial with two agents
34. An example of a phase I trial with ordered groups
35. Single vs. separate trials
36. Bayesian designs for 2 agents/ordered groups trial
37. Isotonic designs for 2 agents/ordered group trials
38. References (1)
39. References (2)
40. References (3)
41. Additional reading

Topics Covered

• Maximum tolerable dose
• Standard or 3+3 design
• A+B designs
• Phase I trials that use toxicity grades
• Escalation versus fixed sample size designs for dose-finding trials
• Continual reassessment method
• Cumulative cohort design
• Start-up rule
• Design modifications for delayed toxicity outcomes
• Trials with two agents and ordered groups

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. Anastasia Ivanova has not informed HSTalks of any commercial/financial relationship that it is appropriate to disclose.