11 Clinical Trial
This chapter provides a comprehensive overview of statistics in clinical trials, outlining the clinical statistician’s role in protocol development, sample size determination, randomization, interim monitoring, and regulatory reporting; it details hypothesis testing for continuous and Poisson endpoints, derivation of sample size formulas under type I/II error constraints, classical group sequential methods and Bayesian sequential procedures for interim analyses, and emphasizes proper randomization, allocation concealment, and safety monitoring to ensure methodological rigor and regulatory compliance.