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In This Chapter
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Clinical Trial Simulations: Later Development Phases
- Introduction
- Overview of Adaptive Design
- Utility-Based Trial Objective
- Dose–Response Model
- Adaptation Rules
- Response-Adaptive Randomizations
- Null Model vs. Model Approach
- Test Statistic
- α-Adjustment
- Bias due to Adaptive Randomization RPW(1,1)
- Simulation Examples
- Example 1: Conventional Design with Two Parallel Treatment Groups
- Example 2: Flexible Design with Sample Size Reestimation
- Example 3: Design with RPW Randomization
- Example 4: Group Sequential Design with One Interim Analysis
- Example 5: Adaptive Design Permitting Early Stopping and Sample Size Reestimation
- Example 6: Conventional Design with Multiple Treatment Groups
- Example 7: Response-Adaptive Design with Multiple Treatment Groups
- Example 8: Adaptive Design with Dropping Losers
- Example 9: Dose Response Trial Design
- Discussion of Simulation Results
- Conclusions
- References
Abstract
Clinical trial simulation plays and important role in drug development and, in recent years, it has become increasingly popular in the pharmaceutical industry. The focus of this entry is the simulation for adaptive trial designs, which will be defined in detail through several statistical examples.
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