Handbook of Adaptive Designs in Pharmaceutical and Clinical Development (eBook, ePUB)

Redaktion: Pong, Annpey; Chow, Shein-Chung

• Format: ePub

Produktbeschreibung

This handbook 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 and presents real-world examples of a range of adaptive designs. Leading clinical researchers in the pharmaceutical industry, academia, and regulatory agencies examine issues commonly encountered when applying adaptive design methods in clinical trials. They discuss the importance of sample size estimation/allocation, justification, and adjustment when implementing a complicated adaptive design.

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Produktdetails

• Verlag: Taylor & Francis eBooks
• Erscheinungstermin: 19. April 2016
• Englisch
• ISBN-13: 9781040204092
• Artikelnr.: 73302672

Autorenporträt

Annpey Pong is a manager in the Department of Biostatistics and Research Decision Sciences at Merck Research Laboratories. Dr. Pong is also the associate editor of the Journal of Biopharmaceutical Statistics. She earned her Ph.D. in statistics from Temple University. Shein-Chung Chow is a professor in the Department of Biostatistics and Bioinformatics at Duke University School of Medicine. Dr. Chow is also a professor of clinical sciences at Duke-National University of Singapore Graduate Medical School and the editor of the Journal of Biopharmaceutical Statistics. He earned his Ph.D. in statistics from the University of Wisconsin-Madison.

Inhaltsangabe

Overview of Adaptive Design Methods in Clinical Trials. Fundamental Theory
of Adaptive Designs with Unplanned Design Change in Clinical Trials with
Blinded Data. Bayesian Approach for Adaptive Design. The Impact of Protocol
Amendments in Adaptive Trial Designs. From Group Sequential to Adaptive
Designs. Determining Sample Size for Classical Designs. Sample Size
Reestimation Design with Applications in Clinical Trials. Adaptive Interim
Analyses in Clinical Trials. Classical Dose-Finding Trial. Improving
Dose-Finding: A Philosophic View. Adaptive Dose-Ranging Studies. Seamless
Phase I/II Designs. Phase II/III Seamless Designs. Sample Size
Estimation/Allocation for Two-Stage Seamless Adaptive Trial Designs.
Optimal Response-Adaptive Randomization for Clinical Trials.
Hypothesis-Adaptive Design. Treatment Adaptive Allocations in Randomized
Clinical Trials: An Overview. Integration of Predictive Biomarker
Diagnostics into Clinical Trials for New Drug Development. Clinical
Strategy for Study Endpoint Selection. Adaptive Infrastructure. Independent
Data Monitoring Committees. Targeted Clinical Trials. Functional
Genome-Wide Association Studies of Longitudinal Traits. Adaptive Trial
Simulation. Efficiency of Adaptive Designs. Cases Studies in Adaptive
Design. Good Practices for Adaptive Clinical Trials. Index.