| Description |
1 online resource (303 p.) |
| Series |
Chapman and Hall/CRC Biostatistics Series |
|
Chapman & Hall/CRC biostatistics series.
|
| Contents |
Cover -- Half Title -- Series Information -- Title Page -- Copyright Page -- Table of Contents -- About the Editors -- List of Contributors -- 1 Review of Advances in Complex Innovative Trials -- 1.1 Innovative Trial Designs -- 1.1.1 Bayesian Adaptive Designs -- 1.1.2 Bayesian Adaptive Design Case Study -- 1.1.3 Master Protocols -- 1.1.4 Master Protocol Case Studies -- 1.2 Endpoints and Analysis -- 1.2.1 Endpoint and Analysis Case Study -- 1.3 Real-World Data/Real-World Evidence -- 1.3.1 RWD/RWE Case Studies -- 1.4 Artificial Intelligence and Machine Learning -- 1.4.1 AI/ML Case Study |
|
1.5 Decentralization and Diversity -- 1.4.2 Case Studies in Decentralization and Diversity -- 1.5 Challenges and Opportunities -- References -- 2 ANBL1531: The Children's Oncology Group (COG) Experience Using a Bayesian Approach -- 2.1 Background -- 2.2 Trial Design Overview -- 2.2.1 Bayesian Predictive Probabilities -- 2.2.2 Original Bayesian Adaptive Design Features -- 2.2.3 Final Design -- 2.3 Review Process and Revision of the Initial Trial Design -- 2.3.1 Adaptive Randomization -- 2.3.2 Arm Dropping and Early Stopping -- 2.3.3 Secondary Comparison -- 2.3.4 Trial Conduct |
|
2.3.5 Impact On Operating Characteristics -- 2.4 Discussion -- References -- 3 Being SMART About Behavioral Intervention Trials for the Management of Chronic Conditions... -- Introduction -- 3.1 Adaptive Interventions -- 3.1.1 Components of an Adaptive Intervention -- 3.2 Sequential Multiple Assignment Randomized Trials (SMARTs) -- 3.2.1 Advantages of SMARTs -- 3.3 Overview of Two Behavioral Pilot SMART Studies -- 3.4 Lessons Learned: Key Methodological and Practical Decisions -- 3.4.1 Critical Decision Points -- 3.4.2 Tailoring Variables -- 3.4.3 Intervention Options -- 3.4.4 Decision Rules |
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3.5 Discussion -- References -- 4 Adapting the Primary Endpoint of TULIP 2 -- A Hybrid Bayesian-Frequentist Framework to Incorporate... -- Introduction and Overview of Technical Area -- 4.1 Anifrolumab Case Study -- 4.2 Lessons Learned -- References -- 5 Unblinded Sample Size Reestimation: A Case Study -- Introduction -- 5.1 Outline of the Study Design -- 5.2 Statistical Considerations -- 5.3 Sample Size Reassessment Design -- 5.4 Logistics and Operational Considerations -- 5.5 Outcome of Interim Analysis -- 5.6 Final Analysis -- 5.7 Choice of Weights Over the Two Stages -- 5.8 Discussion |
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Acknowledgment -- References -- 6 Evaluation of a Method for Sample Size Reestimation for a Confirmatory Phase 3 Clinical Trial to Compare Two Test Treatments to Control -- Introduction -- 6.1 Introduction to Suvorexant Development Program -- 6.2 Methods -- 6.3 Application of Methods to Suvorexant Trial Design -- Simulations -- 6.3.1 Simulation Specifications -- 6.3.2 Single Primary Endpoint -- 6.3.3 Coprimary Endpoints -- 6.3.4 Dual Primary Endpoints -- 6.3.5 Primary Endpoint and Key Secondary Endpoint -- 6.3.6 Simulation Results -- Type I Error -- 6.3.6.1 Single Endpoint |
| Notes |
Description based upon print version of record |
|
6.3.6.2 Coprimary Endpoints |
| Form |
Electronic book
|
| Author |
Yu, Binbing
|
| ISBN |
9781000987218 |
|
1000987213 |
|
