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Clinical Trial Biostatistics and Biopharmaceutical Applications

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

Print publication date:  November  2014
Online publication date:  November  2014

Print ISBN: 9781482212181
eBook ISBN: 9781482212198
Adobe ISBN:

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Book description

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.

Table of contents

Chapter  1:  Emerging Challenges of Clinical Trial Methodologies in Regulatory Applications Download PDF
Chapter  2:  Review of Randomization Methods in Clinical Trials Download PDF
Chapter  3:  First Dose Ranging Clinical Trial Design: More Doses? Or a Wider Range? Download PDF
Chapter  4:  Thorough QT/QTc Clinical Trials Download PDF
Chapter  5:  Controversial (Unresolved) Issues in Noninferiority Trials Download PDF
Chapter  6:  Adaptive Designs in Drug Development Download PDF
Chapter  7:  Optimizing Group-Sequential Designs with Focus on Adaptability: Implications of Nonproportional Hazards in Clinical Trials Download PDF
Chapter  8:  Group Sequential Design in R Download PDF
Chapter  9:  Issues in the Design and Analysis of Oncology Clinical Trials Download PDF
Chapter  10:  Competing Risks and Their Applications in Cancer Clinical Trials Download PDF
Chapter  11:  Dose Finding with Escalation with Overdose Control in Cancer Clinical Trials Download PDF
Chapter  12:  Interval-Censored Time-to-Event Data and Their Applications in Clinical Trials Download PDF
Chapter  13:  Introduction to Multiple Test Problems, with Applications to Adaptive Designs Download PDF
Chapter  14:  Graphical Approaches to Multiple Testing Download PDF
Chapter  15:  Pairwise Comparisons with Binary Responses: Multiplicity-Adjusted P-Values and Simultaneous Confidence Intervals Download PDF
Chapter  16:  Comparative Study of Five Weighted Parametric Multiple Testing Methods for Correlated Multiple Endpoints in Clinical Trials Download PDF
Chapter  17:  Statistical Analysis of Biomarkers from -Omics Technologies Download PDF
Chapter  18:  Understanding Therapeutic Pathways via Biomarkers and Other Uses of Biomarkers in Clinical Studies Download PDF
Chapter  19:  Statistical Evaluation of Surrogate Endpoints in Clinical Studies Download PDF
prelims Download PDF
Index Download PDF
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