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Data Monitoring Committee Training Lecture Two: DMC Examples 1.1 - PDF document

Data Monitoring Committee Training Lecture Two: DMC Examples 1.1 DMC Examples 1.2 Overview of Examples 1.3 Review of Previous Lectures 1.4 Study Organization 1.5 Responsibilities of Key Groups During the Trial 1.6 DMC Recommendations 1.7


  1. Data Monitoring Committee Training Lecture Two: DMC Examples 1.1 DMC Examples 1.2 Overview of Examples

  2. 1.3 Review of Previous Lectures 1.4 Study Organization

  3. 1.5 Responsibilities of Key Groups During the Trial 1.6 DMC Recommendations

  4. 1.7 Early Termination Reasons #1 1.8 Early Termination Reasons #2

  5. 1.9 Early Termination Reasons #3 1.10 Typical DMC Meeting Format

  6. 1.11 Trial Examples Menu 2. CPCRA 002 ddI/ddC Trial 2.1 CPCRA 002 ddI/ddC trial

  7. 2.2 ddI/ddC trial overview 2.3 ddI/ddC Baseline Characteristics

  8. 2.4 DMC Interim Analysis Challenge 2.5 Interim Results of the ddI/ddC Trial

  9. 2.6 DMC Decision 2.7 Interim Results of the ddI/ddC Trial cont'd

  10. 2.8 Importance of DMC flexibility 2.9 ddI/ddC Final results

  11. 2.10 ddI/ddC Lessons Learned 2.11 Importance of accumulated results

  12. 2.12 Impact of FDA approval on trial 3. Physician's Health Study Aspirin/Placebo 3.1 Physician's Health Study

  13. 3. 2 Physician’s Health Study Hypothesis 3. 3 Physician’s Health Study Design

  14. 3.4 Decision to Recommend Stopping 3.5 Aspirin Component

  15. 3.6 Early Termination Issues 3.7 Early Termination Issues Cont'd

  16. 3.8 Lessons Learned 3.9 PHS Conditional Power Estimates

  17. 4. INSIGHT SMART Trial 4.1 INSIGHT SMART trial 4.2 The Setting of SMART Design

  18. 4.3 The Setting of SMART Design cont'd 4.4 The SMART Study Question

  19. 4.5 SMART Study Design 4.6 SMART Study Design cont'd

  20. 4.7 Data and Safety Monitoring Board 4.8 Data and Safety Monitoring Board cont'd

  21. 4.9 Early Termination Guidelines 4.10 Secondary Outcome

  22. 4.11 Early Termination Guidelines quote 4.12 November 2004 DSMB

  23. 4.13 Nov 2004 Monitoring Boundaries 4.14 Nov 2004 Monitoring Boundaries cont'd

  24. 4.15 November 2005 DSMB 4.16 Nov 2005 Monitoring Boundaries

  25. 4.17 Nov 2005 Monitoring Boundaries cont'd 4.18 Jan 2006 DSMB Call

  26. 4.19 Jan 2006 Monitoring Boundaries 4.20 DSMB Recommendations

  27. 4.21 Executive Committee 4.22 Interim Monitoring

  28. 4.23 SMART Primary and Supportive endpoint results 4.24 Lessons Learned

  29. 4.25 Tension Between Various Results 5. CPCRA 001 TOXO Study 5.1 CPCRA 001 TOXO Study

  30. 5.2 CPCRA TOXO Study Overview 5.3 Initial Design

  31. 5.4 TOXO Protocol History 5.5 Revised Design and Recruitment Goals

  32. 5.6 Toxo Baseline Characteristics 5.7 TOXO Protocol History cont'd

  33. 5.8 TOXO Protocol History cont'd 5.9 Number of Deaths / Rate by Treatment Group

  34. 5.10 TOXO Protocol History cont'd 5.11 Number of Deaths cont'd

  35. 5.12 Lessons Learned 5.13 DMC Reaffirming Recommendations

  36. 6. CPCRA 007 NuCombo and Delta 6.1 CPCRA 007 NuCombo and Delta 6.2 CPCRA 007 NuCombo Study Overview

  37. 6.3 CPCRA 007 NuCombo Study Overview cont'd 6.4 CPCRA NuCombo Diagram

  38. 6.5 NuCombo Interim Results: Late 1993 6.6 Is the ddI placebo inert?

  39. 6.7 NuCombo and Delta DMCs Share Data 6.8 Lessons Learned

  40. 6.9 NuCombo/Delta Comments 7. MERIT-HF 7.1 MERIT-HF

  41. 7.2 MERIT HF Trial Overview 7.3 Data Monitoring for MERIT-HF Trial

  42. 7.4 Monitoring Guidelines 7.5 MERIT-HF Study Design

  43. 7.6 MERIT-HF Entry Characteristics 7.7 Total Mortality

  44. 7.8 MERIT-HF Monitoring Bounds for Total Mortality 7.9 Relative Risk and 95% Confidence Interval

  45. 7.10 Relative Risk 7.11 MERIT-HF Study Conclusion

  46. 7.12 Maintaining Confidentiality 8. Trials Reacting to External Data 8.1 Trial Examples: External Data

  47. 8.2 Three Trials List 8.3 Background: General Requirements for Informed Consent

  48. 8.4 Types of New External Information 8.5 Responsibilities Concerning External Information

  49. 8.6 Considerations in Review of External Information by the DMC 8.7 BEST Trial Overview

  50. 8.8 BEST Design 8.9 BEST Timeline of Events

  51. 8.10 BEST Timeline of Events cont'd 8.11 Mortality Results of CIBIS-II, MERIT-HF and BEST

  52. 8.12 BETA-BLOCKER HF TRIALS 8.13 BEST Aftermath

  53. 8.14 Concorde HIV Study 8.15 Concorde Design

  54. 8.16 Concorde DMC Deliberations 8.17 Concorde DMC Deliberations (2)

  55. 8.18 Concorde DMC Deliberations (3) 8.19 Concorde DMC Deliberations (4)

  56. 8.20 ACTG 019 and Interim Concorde Results Sep 1989 8.21 Final Concorde Study Results

  57. 8.22 Overview of Trials of ZDV vs. Placebo 8.23 Concorde HIV - Lessons Learned

  58. 8.24 CPCRA 023: CMV Prophylaxis Trial 8.25 CPCRA 023 Design

  59. 8.26 CPCRA 023 Timeline of Events 8.27 CPCRA 023 Timeline Cont'd

  60. 8.28 Syntex and Interim CPCRA 023 Results July 1994 8.29 Final CPCRA 023 Results

  61. 8.30 Lessons Learned 8.31 Need For Replication

  62. 8.32 Sharing Data 9. COPD Trial 9.1 Chronic Obstructive Pulmonary Disease

  63. 9.2 COPD Overview 9.3 The Nocturnal Oxygen Therapy Trial

  64. 9.4 Possible NOTT Surrogates Outcomes 9.5 NOTT Survival Experience

  65. 9.6 NOTT Data Flow Problem 9.7 NOTT Mortality Results

  66. 9.8 NOTT Mortality Results cont'd 9.9 NOTT: Lesson in Data Collection

  67. 9.10 Data Lags and Subgroup Findings 9.11 Importance of Statistical Analysis Center

  68. 9.12 End of Lecture Two

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