Clinical Trial Simulations Chapman & Hall/CRC Biostatistics Series

In biopharmaceutical statistics, simulation plays an indispensable role. Statisticians conduct simulation studies to thoroughly characterize different statistical methodologies and to compare their performance in terms of type I error, power, sample sizes, etc. This book offers programming codes (SAS and/or R), introduction of both classical and adaptive designs, practical applications of these designs, and introduction of special clinical trial designs such as dose response studies, or biomarker informed adaptive designs.

Introduction to Simulations. Classical Designs. Group Sequential Designs. Sample Size Re-estimation (including Chen & DeMets Method). Conditional Error Method. Dose Response Modeling. Biomarker Adaptive Design (including Jenkins at al. method). Multiple Endpoints Adaptive Designs. Continuous Reassessment Methods. Evaluation of Adaptive Designs.