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Examples From Medical Device Clinical Trials To Illustrate Advantages Of The Bayesian Approach
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Examples From Medical Device Clinical Trials To Illustrate Advantages Of The Bayesian Approach

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Examples from Medical Device Clinical Trials to Illustrate Advantages of the Bayesian Approach

Examples from Medical Device Clinical Trials to Illustrate Advantages of the Bayesian Approach

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Examples From Medical Device Clinical Trials To Illustrate Advantages Of The Bayesian Approach Presentation Transcript

  • 1. Economic and Statistical Analysis of Healthcare Technology
    Teresa Nelson, MS
    Principal Statistician ©Technomics Research 2009
  • 2. Getting Started
  • 3. Outline
  • 4. Bayesian Jokes
    Stat #2 shoots left
    Stat #1 shoots right
  • 5. FDA Requirements for Bayesian Designs
  • 6. Example #1 - Utilization of Prior Data to Reduce Overall Sample Size by Two Methods
  • 7. Example #1 - Utilization of Prior Data to Reduce Overall Sample Size
  • 8. Example #1 - Utilization of Pilot Data via the Prior Data to Reduce Overall Sample Size
    Prior Distributions
    N=75, p=65%,
    # success=49
    N=19, p=63%,
    # success=12
    N=6, p=66%,
    # success = 4
    Non-informative, N=2, p=50%, # success=1
  • 9. Example #1 - Utilization of Pilot Data via the Prior to Reduce Overall Sample Size – Operating Characteristics
  • 10. Example #1 - Utilization of Pilot Data via a Hierarchical Model
    Pools Pilot and Pivotal Study Results for Treatment
    Pcontrol - Ptreatment
    Patient Success
    due to Control
    Patient Success
    due to Treatment
    Uses Only Pivotal Study Control Group Results
    Pilot Study
    Patient Success
    Pivotal Study
    Patient Success
  • 11. Example #1 - Utilization of Pilot Data via Hierarchical Model – Operating Characteristics
  • 12. Example #1 – Regulatory Update
  • 13. Example #1 – Summary and Advantages
  • 14. Example #2 - Incorporation of Multiple Looks Via A Bayesian Design Allows Earlier Trial Stopping
  • 15. Example #2 - Incorporation of Multiple Looks Via A Bayesian Design Allows Earlier Trial Stopping – Frequentist and Bayesian Designs
  • 16. Ex. #2 -Incorporation of Multiple Looks Via A Bayesian Design Allows Earlier Trial Stopping – Operating Characteristics
  • 17. Ex. #2: Incorporation of Multiple Looks Via A Bayesian Design Allows Earlier Trial Stopping – Compare Bayesian and Frequentist Design
  • 18. Ex. #2: Incorporation of Multiple Looks Via A Bayesian Design Allows Earlier Trial Stopping – Compare Bayesian and Frequentist Design
  • 19. Regulatory Update – Example #2
  • 20. Example #2 – Summary and Advantages
  • 21. Example # 3 - Utilization of predictive distribution to calculate probability of a successful trial result
  • 22. Example #3 – Predictive Distribution
  • 23. Example #3 – Results reviewed by DSMB
  • 24. Example #3 – Predictive Distribution Results
  • 25. Example #3 - Another Possible Scenario
  • 26. Example #3 – Is it Futile to Continue?
  • 27. Example #3 – Regulatory Update and Summary and Advantages
  • 28. Example # 4 - Interesting Application for Bayesian Meta-Analysis
  • 29. Example #4 - Bayesian Solution
  • 30. Example #4: Bayesian Meta-Analysis
  • 31. Example #4: Bayesian Meta-Analysis
  • 32. Example #4: Bayesian Meta-Analysis
  • 33. Example #4 – Bayesian Hierarchical Model for Meta-Analysis for Device Experience
  • 34. Example #4 - Bayesian Random Effects Model for Meta-Analysis of Device Experience
  • 35. Example #4 - Bayesian Random Effects Model for Meta-Analysis of Control Experience
  • 36. Example #4 – Bayesian Meta-Analysis
  • 37. Example #4 – Bayesian Meta-Analysis
    Results cont’d.
  • 38. Additional Features to Bayesian Designs
    Results cont’d.
  • 39. Priors for Sensitivity Analysis
    *Assumes a 3% mortality rate
  • 40. Results of Sensitivity Analysis on Hierarchical Model
  • 41. Results of Sensitivity Analysis on Random Effects Models
  • 42. An Example where Bayesian Hierarchical Modeling was Used to Garner FDA Approval
  • 43. Summary - Advantages to Bayesian Trial Design
  • 44. Thank you!
    Teresa Nelson, MS
    Ph: 218 463 5627
    tnelson@technomicsresearch.com
    www.technomicsresearch.com
  • 45. If interested in contracting our services please contact:
    Kim Martinson
    Vice President-Business Development
    Email: Kmartinson@TechnomicsResearch.com
    Ph: 218-331-2272
    www.technomicsresearch.com