Principles and Practice of Clinical Research:Principles and Practice of Clinical Research

Abstract

This chapter aims to provide an intuitive explanation of the statistical principles used in medical research. In particular, the chapter discusses the principles of biostatistics related to the types of studies conducted at the National Institutes of Health (NIH). The discussions include the issues in randomization and study design, comparison of randomized experimental studies to nonrandomized observational studies, and the difficulties of nonrandomized experimental studies. It also describes the theory and mechanisms of randomization and the principles of hypothesis testing from a conceptual perspective. Final discussions are on the intuition behind power and sample size calculations.