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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

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