Multiple Testing Problems in Pharmaceutical Statistics (Hardcover)

Multiplicity Problems in Clinical Trials: A Regulatory Perspective, Mohammad Huque and Joachim Rohmel

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

Multiple Testing Methodology, Alex Dmitrienko, Frank Bretz, Peter H. Westfall, James Troendle, Brian L. Wiens, Ajit C. Tamhane, and Jason C. Hsu

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 in Dose Response Problems, Frank Bretz, Ajit C. Tamhane, and Jose Pinheiro

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
Inferential goals
At-least-one procedures
Global testing procedures
All-or-none procedures
Superiority-noninferiority procedures
Software implementation

Gatekeeping Procedures in Clinical Trials, Alex Dmitrienko and Ajit C. Tamhane

Introduction
Motivating examples
Serial gatekeeping procedures
Parallel gatekeeping procedures
Tree gatekeeping procedures
Software implementation

Adaptive Designs and Confirmatory Hypothesis Testing, Willi Maurer, Michael Branson, and Martin Posch

Introduction
Basic principles and methods of error rate control
Principles of adaptive testing procedures
Adaptive multiple testing procedures
Case studies
Discussion

Design and Analysis of Microarray Experiments for Pharmacogenomics, Jason C. Hsu, Youlan Rao, Yoonkyung Lee, Jane Chang, Kristin Bergsteinsdottir, Magnus Karl Magnusson, Tao Wang, and Eirikur Steingrimsson

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