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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 - - 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
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1.5 Responsibilities of Key Groups During the Trial 1.6 DMC Recommendations
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1.7 Early Termination Reasons #1 1.8 Early Termination Reasons #2
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1.9 Early Termination Reasons #3 1.10 Typical DMC Meeting Format
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1.11 Trial Examples Menu
- 2. CPCRA 002 ddI/ddC Trial
2.1 CPCRA 002 ddI/ddC trial
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2.2 ddI/ddC trial overview 2.3 ddI/ddC Baseline Characteristics
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2.4 DMC Interim Analysis Challenge 2.5 Interim Results of the ddI/ddC Trial
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2.6 DMC Decision 2.7 Interim Results of the ddI/ddC Trial cont'd
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2.8 Importance of DMC flexibility 2.9 ddI/ddC Final results
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2.10 ddI/ddC Lessons Learned 2.11 Importance of accumulated results
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2.12 Impact of FDA approval on trial
- 3. Physician's Health Study Aspirin/Placebo
3.1 Physician's Health Study
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3.2 Physician’s Health Study Hypothesis 3.3 Physician’s Health Study Design
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3.4 Decision to Recommend Stopping 3.5 Aspirin Component
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3.6 Early Termination Issues 3.7 Early Termination Issues Cont'd
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3.8 Lessons Learned 3.9 PHS Conditional Power Estimates
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- 4. INSIGHT SMART Trial
4.1 INSIGHT SMART trial 4.2 The Setting of SMART Design
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4.3 The Setting of SMART Design cont'd 4.4 The SMART Study Question
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4.5 SMART Study Design 4.6 SMART Study Design cont'd
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4.7 Data and Safety Monitoring Board 4.8 Data and Safety Monitoring Board cont'd
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4.9 Early Termination Guidelines 4.10 Secondary Outcome
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4.11 Early Termination Guidelines quote 4.12 November 2004 DSMB
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4.13 Nov 2004 Monitoring Boundaries 4.14 Nov 2004 Monitoring Boundaries cont'd
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4.15 November 2005 DSMB 4.16 Nov 2005 Monitoring Boundaries
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4.17 Nov 2005 Monitoring Boundaries cont'd 4.18 Jan 2006 DSMB Call
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4.19 Jan 2006 Monitoring Boundaries 4.20 DSMB Recommendations
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4.21 Executive Committee 4.22 Interim Monitoring
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4.23 SMART Primary and Supportive endpoint results 4.24 Lessons Learned
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4.25 Tension Between Various Results
- 5. CPCRA 001 TOXO Study
5.1 CPCRA 001 TOXO Study
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5.2 CPCRA TOXO Study Overview 5.3 Initial Design
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5.4 TOXO Protocol History 5.5 Revised Design and Recruitment Goals
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5.6 Toxo Baseline Characteristics 5.7 TOXO Protocol History cont'd
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5.8 TOXO Protocol History cont'd 5.9 Number of Deaths / Rate by Treatment Group
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5.10 TOXO Protocol History cont'd 5.11 Number of Deaths cont'd
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5.12 Lessons Learned 5.13 DMC Reaffirming Recommendations
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- 6. CPCRA 007 NuCombo and Delta
6.1 CPCRA 007 NuCombo and Delta 6.2 CPCRA 007 NuCombo Study Overview
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6.3 CPCRA 007 NuCombo Study Overview cont'd 6.4 CPCRA NuCombo Diagram
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6.5 NuCombo Interim Results: Late 1993 6.6 Is the ddI placebo inert?
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6.7 NuCombo and Delta DMCs Share Data 6.8 Lessons Learned
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6.9 NuCombo/Delta Comments
- 7. MERIT-HF
7.1 MERIT-HF
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7.2 MERIT HF Trial Overview 7.3 Data Monitoring for MERIT-HF Trial
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7.4 Monitoring Guidelines 7.5 MERIT-HF Study Design
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7.6 MERIT-HF Entry Characteristics 7.7 Total Mortality
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7.8 MERIT-HF Monitoring Bounds for Total Mortality 7.9 Relative Risk and 95% Confidence Interval
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7.10 Relative Risk 7.11 MERIT-HF Study Conclusion
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7.12 Maintaining Confidentiality
- 8. Trials Reacting to External Data
8.1 Trial Examples: External Data
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8.2 Three Trials List 8.3 Background: General Requirements for Informed Consent
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8.4 Types of New External Information 8.5 Responsibilities Concerning External Information
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8.6 Considerations in Review of External Information by the DMC 8.7 BEST Trial Overview
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8.8 BEST Design 8.9 BEST Timeline of Events
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8.10 BEST Timeline of Events cont'd 8.11 Mortality Results of CIBIS-II, MERIT-HF and BEST
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8.12 BETA-BLOCKER HF TRIALS 8.13 BEST Aftermath
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8.14 Concorde HIV Study 8.15 Concorde Design
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8.16 Concorde DMC Deliberations 8.17 Concorde DMC Deliberations (2)
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8.18 Concorde DMC Deliberations (3) 8.19 Concorde DMC Deliberations (4)
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8.20 ACTG 019 and Interim Concorde Results Sep 1989 8.21 Final Concorde Study Results
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8.22 Overview of Trials of ZDV vs. Placebo 8.23 Concorde HIV - Lessons Learned
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8.24 CPCRA 023: CMV Prophylaxis Trial 8.25 CPCRA 023 Design
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8.26 CPCRA 023 Timeline of Events 8.27 CPCRA 023 Timeline Cont'd
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8.28 Syntex and Interim CPCRA 023 Results July 1994 8.29 Final CPCRA 023 Results
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8.30 Lessons Learned 8.31 Need For Replication
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8.32 Sharing Data
- 9. COPD Trial
9.1 Chronic Obstructive Pulmonary Disease
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9.2 COPD Overview 9.3 The Nocturnal Oxygen Therapy Trial
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9.4 Possible NOTT Surrogates Outcomes 9.5 NOTT Survival Experience
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9.6 NOTT Data Flow Problem 9.7 NOTT Mortality Results
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9.8 NOTT Mortality Results cont'd 9.9 NOTT: Lesson in Data Collection
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9.10 Data Lags and Subgroup Findings 9.11 Importance of Statistical Analysis Center
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