Real-World Evidence in Drug Development and Evaluation
Harry Yang & Binbing Yu
Medical Risk Prediction Models
Thomas A. Gerds & Michael W. Kattan
Biomarker Analysis in Clinical Trials with R
Nusrat Rabbee
Biosimilar Clinical Development: Scientific Considerations and New Methodologies
Kerry B. Barker, Sandeep M. Menon, Sr. D'Agostino, Siyan Xu & PhD Jin
Innovative Methods for Rare Disease Drug Development
Shein-Chung Chow
Statistical Design, Monitoring, and Analysis of Clinical Trials
Weichung Joe Shih & Joseph Aisner
Signal Detection for Medical Scientists
Ram Tiwari, Jyoti Zalkikar & Lan Huang
Hybrid Frequentist/Bayesian Power and Bayesian Power in Planning Clinical Trials
Andrew P. Grieve
Applied Meta-Analysis with R and Stata
Ding-Geng (Din) Chen & Karl E. Peace
Interface between Regulation and Statistics in Drug Development
Demissie Alemayehu, Birol Emir & Michael Gaffney