Design and analysis of clinical trials for predictive medicine



Design and analysis of clinical trials for predictive medicine

Shigeyuki Matsui, Marc Buyse, Richard Simon

(Chapman & Hall/CRC biostatistics series)

CRC Press, Taylor & Francis, c2015

  • : hardback

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Includes bibliographical references and index



Design and Analysis of Clinical Trials for Predictive Medicine provides statistical guidance on conducting clinical trials for predictive medicine. It covers statistical topics relevant to the main clinical research phases for developing molecular diagnostics and therapeutics-from identifying molecular biomarkers using DNA microarrays to confirming their clinical utility in randomized clinical trials. The foundation of modern clinical trials was laid many years before modern developments in biotechnology and genomics. Drug development in many diseases is now shifting to molecularly targeted treatment. Confronted with such a major break in the evolution toward personalized or predictive medicine, the methodologies for design and analysis of clinical trials is now evolving. This book is one of the first attempts to contribute to this evolution by laying a foundation for the use of appropriate statistical designs and methods in future clinical trials for predictive medicine. It is a useful resource for clinical biostatisticians, researchers focusing on predictive medicine, clinical investigators, translational scientists, and graduate biostatistics students.


INTRODUCTORY OVERVIEW Clinical Trials for Predictive Medicine: New Paradigms and Challenges Richard Simon, Shigeyuki Matsui, and Marc Buyse An Industry Statistician's Perspective on Personalized Health Care Drug Development Jane Fridlyand, Ru-Fang Yeh, Howard Mackey, Thomas Bengtsson, Paul Delmar, Greg Spaniolo, and Grazyna Lieberman Analytical Validation of In Vitro Diagnostic Tests Robert Becker, Jr. EARLY CLINICAL TRIALS USING BIOMARKERS Phase I Dose-Finding Designs and Their Applicability to Targeted Therapies Takashi Daimon, Akihiro Hirakawa, and Shigeyuki Matsui An Overview of Phase II Clinical Trial Designs with Biomarkers Lisa McShane and Sally Hunsberger Bayesian Adaptive Methods for Clinical Trials of Targeted Agents Peter Thall Outcome-Adaptive Randomization in Early Clinical Trials Edward Korn and Boris Freidlin Challenges of Using Predictive Biomarkers in Clinical Trials Sumithra Mandrekar and Daniel Sargent PHASE III RANDOMIZED CLINICAL TRIALS USING BIOMARKERS Comparison of Randomized Clinical Trial Designs for Targeted Agents Antje Hoering, Mike LeBlanc, and John Crowley Phase III All-Comers Clinical Trials with a Predictive Biomarker Shigeyuki Matsui, Yuki Choai, and Takahiro Nonaka Evaluation of Clinical Utility and Validation of Gene Signatures in Clinical Trials Stefan Michiels and Federico Rotolo ANALYSIS OF HIGH-DIMENSIONAL DATA AND GENOMIC SIGNATURE DEVELOPMENTS Statistical Issues in Clinical Development and Validation of Genomic Signatures Shigeyuki Matsui Univariate Analysis for Gene Screening: Beyond Multiple Testing Hisashi Noma and Shigeyuki Matsui Statistical and Machine-Learning Methods for Class Prediction in High Dimension Osamu Komori and Shinto Eguchi Survival Risk Prediction Using High-Dimensional Molecular Data Harald Binder, Thomas Gerds, and Martin Schumacher RANDOMIZED TRIALS WITH BIOMARKER DEVELOPMENT AND VALIDATION Adaptive Clinical Trial Designs with Biomarker Development and Validation Boris Freidlin and Richard Simon Development and Validation of Continuous Genomic Signatures in Randomized Clinical Trials Shigeyuki Matsui EVALUATION OF SURROGATE BIOMARKERS Biomarker-Based Surrogate Endpoints Marc Buyse, Tomasz Burzykowski, Geert Molenberghs, and Ariel Alonso

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