Clinical Trial Biostatistics and Biopharmaceutical Applications: 1st Edition (Hardback) book cover

Clinical Trial Biostatistics and Biopharmaceutical Applications

1st Edition

Edited by Walter R. Young, Ding-Geng (Din) Chen

Chapman and Hall/CRC

580 pages | 73 B/W Illus.

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pub: 2014-11-20
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Since 1945, "The Annual Deming Conference on Applied Statistics" has been an important event in the statistics profession. In Clinical Trial Biostatistics and Biopharmaceutical Applications, prominent speakers from past Deming conferences present novel biostatistical methodologies in clinical trials as well as up-to-date biostatistical applications from the pharmaceutical industry.

Divided into five sections, the book begins with emerging issues in clinical trial design and analysis, including the roles of modeling and simulation, the pros and cons of randomization procedures, the design of Phase II dose-ranging trials, thorough QT/QTc clinical trials, and assay sensitivity and the constancy assumption in noninferiority trials. The second section examines adaptive designs in drug development, discusses the consequences of group-sequential and adaptive designs, and illustrates group sequential design in R. The third section focuses on oncology clinical trials, covering competing risks, escalation with overdose control (EWOC) dose finding, and interval-censored time-to-event data.

In the fourth section, the book describes multiple test problems with applications to adaptive designs, graphical approaches to multiple testing, the estimation of simultaneous confidence intervals for multiple comparisons, and weighted parametric multiple testing methods. The final section discusses the statistical analysis of biomarkers from omics technologies, biomarker strategies applicable to clinical development, and the statistical evaluation of surrogate endpoints.

This book clarifies important issues when designing and analyzing clinical trials, including several misunderstood and unresolved challenges. It will help readers choose the right method for their biostatistical application. Each chapter is self-contained with references.


"This book of timely, self-contained chapters covers a wide range of current methods and unresolved challenges in clinical trial statistical methods and will prove to be an essential guide for biostatisticians who work in this field."

—Dirk F. Moore, Journal of Biopharmaceutical Statistics

". . . the contributed chapters in this collection are clearly written, easily digestible, and well-referenced. The book is a useful resource for the clinical trialist interested in obtaining a quick overview of standard practices and current methodological development for a specific biostatistical application, or a worthwhile read for the researcher seeking to familiarize him or herself with a diversity of emerging topics in clinical trials.

—Megan T. Smith, University of California, Irvine

Table of Contents

Emerging Issues in Clinical Trial Design and Analysis

Emerging Challenges of Clinical Trial Methodologies in Regulatory Applications H.M. James Hung and Sue-Jane Wang

Review of RandomizationMethods in Clinical Trials Vance W. Berger and William C. Grant

First Dose Ranging Clinical Trial Design: More Doses? Or a Wider Range? Guojun Yuan and Naitee Ting

Thorough QT/QTc Clinical Trials Yi Tsong

Controversial (Unresolved) Issues in Noninferiority Trials Brian L. Wiens

Adaptive Clinical Trials

Adaptive Designs in Drug Development Sue-Jane Wang and H.M. James Hung

Optimizing Group-Sequential Designs with Focus on Adaptability: Implications of Nonproportional Hazards in Clinical Trials Edward Lakatos

Group Sequential Design in R Keaven M. Anderson

Clinical Trials in Oncology

Issues in the Design and Analysis of Oncology Clinical Trials Stephanie Green

Competing Risks and Their Applications in Cancer Clinical Trials Chen Hu, James J. Dignam, and Ding-Geng (Din) Chen

Dose Finding with Escalation with Overdose Control in Cancer Clinical Trials André Rogatko and Mourad Tighiouart

Interval-Censored Time-to-Event Data and Their Applications in Clinical Trials Ling Ma, Yanqin Feng, Ding-Geng (Din) Chen, and Jianguo Sun

Multiple Comparisons in Clinical Trials

Introduction to Multiple Test Problems, with Applications to Adaptive Designs Jeff Maca, Frank Bretz, and Willi Maurer

Graphical Approaches to Multiple Testing Frank Bretz, Willi Maurer, and Jeff Maca

Pairwise Comparisons with Binary Responses: Multiplicity-Adjusted P-Values and Simultaneous Confidence Intervals Bernhard Klingenberg and Faraz Rahman

Comparative Study of FiveWeighted Parametric Multiple Testing Methods for Correlated Multiple Endpoints in Clinical Trials Changchun Xie, Xuewen Lu, and Ding-Geng (Din) Chen

Clinical Trials in the Genomic Era

Statistical Analysis of Biomarkers from Omics Technologies Herbert Pang and Hongyu Zhao

Understanding Therapeutic Pathways via Biomarkers and Other Uses of Biomarkers in Clinical Studies Michael D. Hale and Scott D. Patterson

Statistical Evaluation of Surrogate Endpoints in Clinical Studies Geert Molenberghs, Ariel Alonso Abad, Wim Van der Elst, Tomasz Burzykowski, and Marc Buyse


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Subject Categories

BISAC Subject Codes/Headings:
MATHEMATICS / Probability & Statistics / General
MEDICAL / Pharmacology
MEDICAL / Biostatistics