Handbook of Adaptive Designs in Pharmaceutical and Clinical Development: 1st Edition (Hardback) book cover

Handbook of Adaptive Designs in Pharmaceutical and Clinical Development

1st Edition

Edited by Annpey Pong, Shein-Chung Chow

CRC Press

496 pages | 60 B/W Illus.

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Hardback: 9781439810163
pub: 2010-10-25
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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

Overview of Adaptive Design Methods in Clinical Trials, Annpey Pong and Shein-Chung Chow

Fundamental Theory of Adaptive Designs with Unplanned Design Change in Clinical Trials with Blinded Data, Qing Liu and George Y.H. Chi

Bayesian Approach for Adaptive Design, Guosheng Yin and Ying Yuan

The Impact of Protocol Amendments in Adaptive Trial Designs, Shein-Chung Chow and Annpey Pong

From Group Sequential to Adaptive Designs, Christopher Jennison and Bruce W. Turnbull

Determining Sample Size for Classical Designs, Simon Kirby and Christy Chuang-Stein

Sample Size Reestimation Design with Applications in Clinical Trials, Lu Cui and Xiaoru Wu

Adaptive Interim Analyses in Clinical Trials, Gernot Wassmer

Classical Dose-Finding Trial, Naitee Ting

Improving Dose-Finding: A Philosophic View, Carl-Fredrik Burman, Frank Miller, and Kiat Wee Wong

Adaptive Dose-Ranging Studies, Marc Vandemeulebroecke, Frank Bretz, José Pinheiro, and Björn Bornkamp

Seamless Phase I/II Designs, Vladimir Dragalin

Phase II/III Seamless Designs, Jeff Maca

Sample Size Estimation/Allocation for Two-Stage Seamless Adaptive Trial Designs, Shein-Chung Chow and Annpey Pong

Optimal Response-Adaptive Randomization for Clinical Trials, Lanju Zhang and William Rosenberger

Hypothesis-Adaptive Design, Gerhard Hommel

Treatment Adaptive Allocations in Randomized Clinical Trials: An Overview, Atanu Biswas and Rahul Bhattacharya

Integration of Predictive Biomarker Diagnostics into Clinical Trials for New Drug Development, Richard Simon

Clinical Strategy for Study Endpoint Selection, Siu Keung Tse, Shein-Chung Chow, and Qingshu Lu

Adaptive Infrastructure, Bill Byrom, Damian McEntegart, and Graham Nicholls

Independent Data Monitoring Committees, Steven Snapinn and Qi Jiang

Targeted Clinical Trials, Jen-Pei Liu

Functional Genome-Wide Association Studies of Longitudinal Traits, Jiangtao Luo, Arthur Berg, Kwangmi Ahn, Kiranmoy Das, Jiahan Li, Zhong Wang, Yao Li, and Rongling Wu

Adaptive Trial Simulation, Mark Chang

Efficiency of Adaptive Designs, Nigel Stallard and Tim Friede

Cases Studies in Adaptive Design, Ning Li, Yonghong Gao, and Shiowjen Lee

Good Practices for Adaptive Clinical Trials, Paul Gallo

Index

About the Editors

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.

Subject Categories

BISAC Subject Codes/Headings:
MAT029000
MATHEMATICS / Probability & Statistics / General
MED071000
MEDICAL / Pharmacology
MED072000
MEDICAL / Pharmacy