ABSTRACT
This chapter discusses the background of randomised controlled clinical trials and the main factors that should be considered in their design. It describes the issues associated with clinical trial design in the context of assessing innovative therapies.
It provides a detailed description of the different types of clinical trials for different objectives. It highlights how these different objectives impact study design with respect to the derivation of formulae for sample size calculations.
It further explains that when undertaking a clinical trial, we are looking to make inferences about true population responses and that how these inferences could lead to errors, including false positive (Type I errors) or false negative (Type II errors).
