This cluster of papers covers a wide range of statistical methods and design considerations in the context of clinical trials and drug development. It includes topics such as controlling the false discovery rate, adaptive trial designs, noninferiority trials, biomarkers, phase I trials, multiple testing, Bayesian methods, sample size determination, composite endpoints, and pharmacokinetic/pharmacodynamic modeling.
False Discovery Rate; Adaptive Designs; Noninferiority Trials; Biomarkers; Phase I Trials; Multiple Testing; Bayesian Methods; Sample Size; Composite Endpoints; Pharmacokinetic/Pharmacodynamic Modeling