Biomarker Analysis in Clinical Trials with R

1st Edition

Nusrat Rabbee

Chapman and Hall/CRC
April 2, 2020 Forthcoming
Reference - 232 Pages - 38 B/W Illustrations
ISBN 9781138368835 - CAT# K397104
Series: Chapman & Hall/CRC Biostatistics Series

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Biomarker Analysis in Clinical Trials with R offers practical guidance to statisticians in the pharmaceutical industry on how to incorporate biomarker data analysis in clinical trial studies. The book discusses the appropriate statistical methods for evaluating pharmacodynamic, predictive and surrogate biomarkers for delivering increased value in the drug development process. The topic of combining multiple biomarkers to predict drug response using machine learning is covered. Featuring copious reproducible code and examples in R, the book helps students, researchers and biostatisticians get started in tackling the hard problems of designing and analyzing trials with biomarkers.


    • Analysis of pharmacodynamic biomarkers for lending evidence target modulation.
    • Design and analysis of trials with a predictive biomarker.
    • Framework for analyzing surrogate biomarkers.
    • Methods for combining multiple biomarkers to predict treatment response.
    • Offers a biomarker statistical analysis plan.
    • R code, data and models are given for each part: including regression models for survival and longitudinal data, as well as statistical learning models, such as graphical models and penalized regression models.

Nusrat Rabbee is a biostatistician and data scientist at Eisai, Inc., where she leads Statistical Methodology in Neurology. Her research is in the development of statistical methods and computational tools for personalized treatment. She has co-discovered the RLMM algorithm for genotyping Affymetrix SNP chips and co-invented a high-dimensional molecular signature for cancer. She has spent over sixteen years in the pharmaceutical and diagnostics industry. She has taught Statistics at UC Berkeley for four years.


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