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In This Chapter
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Adaptive Design Methods in Clinical Trials
- Introduction
- What is Adaptive Design?
- Adaptations
- Types of Adaptive Designs
- Adaptive Randomization Design
- Group Sequential Design
- Flexible Sample Size Re-Estimation (SSRE) Design
- Drop-The-Losers Design
- Adaptive Dose Finding Design
- Biomarker-Adaptive Design
- Adaptive Treatment-Switching Design
- Adaptive-Hypotheses Design
- Seamless Adaptive Trial Design
- Multiple Adaptive Design
- Regulatory/Statistical Perspectives
- Impact, Challenges, and Obstacles
- Impact of Protocol Amendments
- Challenges in By Design Adaptations
- Obstacles of Retrospective Adaptations
- Some Examples
- Strategies for Clinical Development
- Concluding Remarks
- References
Abstract
The aim of this entry is not only to provide a comprehensive summarization of the issues that are commonly encountered when applying/implementing the adaptive design methods in clinical research but also to include recent development such as the role of the independent data safety monitoring board and sample size estimation/allocation, justification, and adjustment when implementing a much more complicated adaptive design in clinical trials.
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