Design and Analysis of Clinical Trials for Predictive Medicine (eBook, ePUB)

Redaktion: Matsui, Shigeyuki; Simon, Richard; Buyse, Marc

• Format: ePub

Produktbeschreibung

This book offers 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. The book explains how to identify molecular biomarkers using DNA microarrays, validate the developed biomarkers, and confirm their clinical utility in randomized clinical trials.

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Produktdetails

• Verlag: Taylor & Francis eBooks
• Erscheinungstermin: 19. März 2015
• Englisch
• ISBN-13: 9781040219270
• Artikelnr.: 73302961

Autorenporträt

Shigeyuki Matsui is a professor in the Department of Biostatistics at Nagoya University Graduate School of Medicine in Japan. He is also a visiting professor at the Institute of Statistical Mathematics. Dr. Matsui has served as council and nominating committee member of the International Biometric Society. He is currently council of the Biometric Society of Japan (BSJ) and editor-in-chief of the Japanese Journal of Biometrics. He is the recipient of the 2014 Award from the BSJ. Dr. Matsui is also a frequent reviewer commissioned by government and advisor to pharmaceutical companies in Japan. He holds degrees in engineering from the Tokyo University of Science in Japan. Marc E. Buyse is the founder of the International Drug Development Institute in Louvain-la-Neuve, Belgium and of CluePoints Inc. in Cambridge, Massachusetts. He is also an associate professor of biostatistics at Hasselt University in Belgium. He was president of the International Society for Clinical Biostatistics, president of the Quetelet Society, and fellow of the Society for Clinical Trials. He worked at the European Organization for Research and Treatment of Cancer in Brussels and at the Dana Farber Cancer Institute in Boston. He holds degrees in engineering and statistics from Brussels University, management from the Cranfield School of Management in the UK, and a doctorate in biostatistics from Harvard University. Richard M. Simon is chief of the Biometric Research Branch at the National Cancer Institute in Bethesda, Maryland. He leads a multidisciplinary group of scientists developing and applying methods for the application of genomics to cancer therapeutics. Dr. Simon is the architect of BRB-ArrayTools software used for the analysis of microarray and digital expression, copy number, and methylation data. He is the recipient of the 2013 Karl E. Peace Award for Outstanding Statistical Contributions for the Betterment of Society and is the author or coauthor of more than 450 publications.

Inhaltsangabe

INTRODUCTORY OVERVIEW. Clinical Trials for Predictive Medicine: New
Paradigms and Challenges. An Industry Statistician's Perspective on
Personalized Health Care Drug Development. Analytical Validation of In
Vitro Diagnostic Tests. EARLY CLINICAL TRIALS USING BIOMARKERS. Phase I
Dose-Finding Designs and Their Applicability to Targeted Therapies. An
Overview of Phase II Clinical Trial Designs with Biomarkers. Bayesian
Adaptive Methods for Clinical Trials of Targeted Agents. Outcome-Adaptive
Randomization in Early Clinical Trials. Challenges of Using Predictive
Biomarkers in Clinical Trials. PHASE III RANDOMIZED CLINICAL TRIALS USING
BIOMARKERS. Comparison of Randomized Clinical Trial Designs for Targeted
Agents. Phase III All-Comers Clinical Trials with a Predictive Biomarker.
Evaluation of Clinical Utility and Validation of Gene Signatures in
Clinical Trials. ANALYSIS OF HIGH-DIMENSIONAL DATA AND GENOMIC SIGNATURE
DEVELOPMENTS. Statistical Issues in Clinical Development and Validation of
Genomic Signatures. Univariate Analysis for Gene Screening: Beyond Multiple
Testing. Statistical and Machine-Learning Methods for Class Prediction in
High Dimension. Survival Risk Prediction Using High-Dimensional Molecular
Data. RANDOMIZED TRIALS WITH BIOMARKER DEVELOPMENT AND VALIDATION.
Adaptive Clinical Trial Designs with Biomarker Development and Validation.
Development and Validation of Continuous Genomic Signatures in Randomized
Clinical Trials. EVALUATION OF SURROGATE BIOMARKERS. Biomarker-Based
Surrogate Endpoints.