Handbook of Adaptive Designs in Pharmaceutical and Clinical Development.

Pong, Annpey.
Baton Rouge : Taylor & Francis Group, 2010.
1 online resource (475 pages)
1st ed.

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Clinical trials -- Handbooks, manuals, etc.
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Electronic books.
In response to the US FDA's Critical Path Initiative, innovative adaptive designs are being used more and more in clinical trials due to their flexibility and efficiency, especially during early phase development. Handbook of Adaptive Designs in Pharmaceutical and Clinical Development provides a comprehensive and unified presentation of the principles and latest statistical methodologies used when modifying trial procedures based on accrued data of ongoing clinical trials. The book also gives a well-balanced summary of current regulatory perspectives. The first several chapters focus on the fundamental theory behind adaptive trial design, the application of the Bayesian approach to adaptive designs, and the impact of potential population shift due to protocol amendments. The book then presents a variety of statistical methods for group sequential design, classical design, dose-finding trials, Phase I/II and Phase II/III seamless adaptive designs, multiple stage seamless adaptive trial design, adaptive randomization trials, hypotheses-adaptive design, and treatment-adaptive design. It also covers predictive biomarker diagnostics for new drug development, clinical strategies for endpoint selection in translational research, the role of independent data monitoring committees in adaptive clinical trials, the enrichment process in targeted clinical trials for personalized medicine, applications of adaptive designs that use genomic or genetic information, adaptive trial simulation, and the efficiency of adaptive design. The final chapters discuss case studies as well as standard operating procedures for good adaptive practices. With contributions from leading clinical researchers in the pharmaceutical industry, academia, and regulatory agencies, this handbook offers an up-to-date, complete treatment of the principles and methods of adaptive design and
analysis. Along with reviewing recent developments, it examines issues commonly encountered when applying adaptive design methods in clinical trials.
Front cover
Chapter 1. Overview of Adaptive Design Methods in Clinical Trials
Chapter 2. Fundamental Theory of Adaptive Designs with Unplanned Design Change in Clinical Trials with Blinded Data
Chapter 3. Bayesian Approach for Adaptive Design
Chapter 4. The Impact of Protocol Amendments in Adaptive Trial Designs
Chapter 5. From Group Sequential to Adaptive Designs
Chapter 6. Determining Sample Size for Classical Designs
Chapter 7. Sample Size Reestimation Design with Applications in Clinical Trials
Chapter 8. Adaptive Interim Analyses in Clinical Trials
Chapter 9. Classical Dose-Finding Trial
Chapter 10. Improving Dose-Finding: A Philosophic View
Chapter 11. Adaptive Dose-Ranging Studies
Chapter 12. Seamless Phase I/II Designs
Chapter 13. Phase II/III Seamless Designs
Chapter 14. Sample Size Estimation/Allocation for Two-Stage Seamless Adaptive Trial Designs
Chapter 15. Optimal Response-Adaptive Randomization for Clinical Trials
Chapter 16. Hypothesis-Adaptive Design
Chapter 17. Treatment Adaptive Allocations in Randomized Clinical Trials: An Overview
Chapter 18. Integration of Predictive Biomarker Diagnostics into Clinical Trials for New Drug Development
Chapter 19. Clinical Strategy for Study Endpoint Selection
Chapter 20. Adaptive Infrastructure
Chapter 21. Independent Data Monitoring Committees
Chapter 22. Targeted Clinical Trials
Chapter 23. Functional Genome-Wide Association Studies of Longitudinal Traits
Chapter 24. Adaptive Trial Simulation
Chapter 25. Efficiency of Adaptive Designs
Chapter 26. Case Studies in Adaptive Design
Chapter 27. Good Practices for Adaptive Clinical Trials
Back cover.
Description based on publisher supplied metadata and other sources.
Local notes:
Electronic reproduction. Ann Arbor, Michigan : ProQuest Ebook Central, 2021. Available via World Wide Web. Access may be limited to ProQuest Ebook Central affiliated libraries.
Chow, Shein-Chung.
Other format:
Print version: Pong, Annpey Handbook of Adaptive Designs in Pharmaceutical and Clinical Development