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Featured Series

Multiplicity Problems in Clinical Trials: Introduction Common multiplicity problems in clinical trials Reducing multiplicity in clinical trials Multiplicity concerns in special situations Multiplicity in the analysis of safety endpoints Concluding remarks.

1st Edition

Westfall, James Troendle, Brian L. Tamhane, and Jason C. Introduction Error rate definitions Multiple testing principles Adjusted significance levels, p -values, and confidence intervals Common multiple testing procedures Multiple testing procedures based on univariate p-values Parametric multiple testing procedures Resampling-based multiple testing procedures Software implementation.

Multiple Testing Problems in Pharmaceutical Statistics - CRC Press Book

Introduction Dose response trend tests Target dose estimation using multiple hypothesis testing Power and sample size calculation for target dose estimation Hybrid approaches combining multiple testing and modeling Analysis of Multiple Endpoints in Clinical Trials, Ajit C. Tamhane and Alex Dmitrienko. Introduction Motivating examples Serial gatekeeping procedures Parallel gatekeeping procedures Tree gatekeeping procedures Software implementation.

Introduction Basic principles and methods of error rate control Principles of adaptive testing procedures Adaptive multiple testing procedures Case studies Discussion. Potential uses of biomarkers Clinical uses of genetic profiling Two stages of pharmacogenomic development Multiplicity in pharmacogenomics Designing pharmacogenomic studies Analyzing microarray data by modeling A proof of concept experiment Software implementation Bibliography. Tamhane is senior associate dean and professor of industrial engineering and management sciences in the McCormick School of Engineering and Applied Science at Northwestern University in Illinois.

Multiple Testing Problems in Pharmaceutical Statistics

He is also an adjunct professor at Hannover Medical School in Germany. Descriptions of the procedures are supported with clinical trial-related examples, with many of the chapters providing guidance into the implementation in commonly used software applications SAS and R , making the book a useful tool for biostatisticians dealing with multiple testing problems in clinical trials.

Each chapter begins with an overview of the multiple testing issues faced within different clinical trial settings, which may be of interest to clinical trial practitioners. This book offers a detailed overview of multiple testing methodologies with examples from clinical studies, advice pertaining to regulatory guidelines, and software implementation.


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What makes this book such a valuable resource is its emphasis on recent developments. All chapters in the book are well written and the methodologies are nicely introduced.

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In particular, the diversity of different areas being covered in this book—starting from regulatory issues, up to dose-response problems and ending in microarray experiments—is remarkable. This book is an important contribution to the increasing literature about multiple testing. The book focuses on pharmaceutical statistics with emphasis on clinical research. The methodology and applications described are nonetheless relevant to other fields.

The final chapter focuses on the design of pharmacogenomic studies based on established statistical principles. It also describes the analysis of data collected in these studies, taking into account the numerous multiplicity issues that occur. This volume explains how to solve critical issues in multiple testing encountered in pre-clinical and clinical trial applications.

Multiple Testing Problems in Pharmaceutical Statistics (Chapman & Hall CRC Biostatistics Series)

It presents the necessary statistical methodology, along with examples and software code to show how to use the methods in practice. Tamhane is senior associate dean and professor of industrial engineering and management sciences in the McCormick School of Engineering and Applied Science at Northwestern University in Illinois. He is also an adjunct professor at Hannover Medical School in Germany.

Statistics In the Pharmaceutical Industry, 3rd Edition Chapman & Hall CRC Biostatistics Series

He is also an adjunct professor at Hannover Medical School in Germany. Multiple Testing Problems in Pharmaceutical Statistics.


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Alex Dmitrienko , Ajit C. Tamhane , Frank Bretz. Useful Statistical Approaches for Addressing Multiplicity Issues Includes practical examples from recent trials Bringing together leading statisticians, scientists, and clinicians from the pharmaceutical industry, academia, and regulatory agencies, Multiple Testing Problems in Pharmaceutical Statistics explores the rapidly growing area of multiple comparison research with an emphasis on pharmaceutical applications.

Multiple Testing in DoseResponse Problems.