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 Early Termination Reasons #1 1.8 Early Termination Reasons #2

1.9 Early Termination Reasons #3 1.10 Typical DMC Meeting Format

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

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

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

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

2.8 Importance of DMC flexibility 2.9 ddI/ddC Final results

2.10 ddI/ddC Lessons Learned 2.11 Importance of accumulated results

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

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

3.4 Decision to Recommend Stopping 3.5 Aspirin Component

3.6 Early Termination Issues 3.7 Early Termination Issues Cont'd

3.8 Lessons Learned 3.9 PHS Conditional Power Estimates

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

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

4.5 SMART Study Design 4.6 SMART Study Design cont'd

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

4.9 Early Termination Guidelines 4.10 Secondary Outcome

4.11 Early Termination Guidelines quote 4.12 November 2004 DSMB

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

4.15 November 2005 DSMB 4.16 Nov 2005 Monitoring Boundaries

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

4.19 Jan 2006 Monitoring Boundaries 4.20 DSMB Recommendations

4.21 Executive Committee 4.22 Interim Monitoring

4.23 SMART Primary and Supportive endpoint results 4.24 Lessons Learned

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

5.2 CPCRA TOXO Study Overview 5.3 Initial Design

5.4 TOXO Protocol History 5.5 Revised Design and Recruitment Goals

5.6 Toxo Baseline Characteristics 5.7 TOXO Protocol History cont'd

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

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

5.12 Lessons Learned 5.13 DMC Reaffirming Recommendations

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

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

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

6.7 NuCombo and Delta DMCs Share Data 6.8 Lessons Learned

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

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

7.4 Monitoring Guidelines 7.5 MERIT-HF Study Design

7.6 MERIT-HF Entry Characteristics 7.7 Total Mortality

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

7.10 Relative Risk 7.11 MERIT-HF Study Conclusion

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

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

8.4 Types of New External Information 8.5 Responsibilities Concerning External Information

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

8.8 BEST Design 8.9 BEST Timeline of Events

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

8.12 BETA-BLOCKER HF TRIALS 8.13 BEST Aftermath

8.14 Concorde HIV Study 8.15 Concorde Design

8.16 Concorde DMC Deliberations 8.17 Concorde DMC Deliberations (2)

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

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

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

8.24 CPCRA 023: CMV Prophylaxis Trial 8.25 CPCRA 023 Design

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

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

8.30 Lessons Learned 8.31 Need For Replication

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

9.2 COPD Overview 9.3 The Nocturnal Oxygen Therapy Trial

9.4 Possible NOTT Surrogates Outcomes 9.5 NOTT Survival Experience

9.6 NOTT Data Flow Problem 9.7 NOTT Mortality Results

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

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

9.12 End of Lecture Two