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Handbook of Adaptive Designs in Pharmaceutical and Clinical Development

Edited by: Annpey Pong , Shein-Chung Chow

Print publication date:  October  2010
Online publication date:  April  2016

Print ISBN: 9781439810163
eBook ISBN: 9781439810170
Adobe ISBN:

 Cite  Marc Record

Book description

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.

Table of contents

Chapter  1:  Overview of Adaptive Design Methods in Clinical Trials Download PDF
Chapter  2:  Fundamental Theory of Adaptive Designs with Unplanned Design Change in Clinical Trials with Blinded Data Download PDF
Chapter  3:  Bayesian Approach for Adaptive Design Download PDF
Chapter  4:  The Impact of Protocol Amendments in Adaptive Trial Designs Download PDF
Chapter  5:  From Group Sequential to Adaptive Designs Download PDF
Chapter  6:  Determining Sample Size for Classical Designs Download PDF
Chapter  7:  Sample Size Reestimation Design with Applications in Clinical Trials Download PDF
Chapter  8:  Adaptive Interim Analyses in Clinical Trials Download PDF
Chapter  9:  Classical Dose-Finding Trial Download PDF
Chapter  10:  Improving Dose-Finding Download PDF
Chapter  11:  Adaptive Dose-Ranging Studies Download PDF
Chapter  12:  Seamless Phase I/II Designs Download PDF
Chapter  13:  Phase II/III Seamless Designs Download PDF
Chapter  14:  Sample Size Estimation/Allocation for Two-Stage Seamless Adaptive Trial Designs Download PDF
Chapter  15:  Optimal Response-Adaptive Randomization for Clinical Trials Download PDF
Chapter  16:  Hypothesis-Adaptive Design Download PDF
Chapter  17:  Treatment Adaptive Allocations in Randomized Clinical Trials: An Overview Download PDF
Chapter  18:  Integration of Predictive Biomarker Diagnostics into Clinical Trials for New Drug Development Download PDF
Chapter  19:  Clinical Strategy for Study Endpoint Selection Download PDF
Chapter  20:  Adaptive Infrastructure Download PDF
Chapter  21:  Independent Data Monitoring Committees Download PDF
Chapter  22:  Targeted Clinical Trials Download PDF
Chapter  23:  Functional Genome-Wide Association Studies of Longitudinal Traits Download PDF
Chapter  24:  Adaptive Trial Simulation Download PDF
Chapter  25:  Efficiency of Adaptive Designs Download PDF
Chapter  26:  Case Studies in Adaptive Design  Download PDF
Chapter  27:  Good Practices for Adaptive Clinical Trials Download PDF
prelims Download PDF
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