Multiple Testing Problems in Pharmaceutical Statistics

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