A fundamental understanding of clinical trials methods is critical to the role of both the clinical research nurse and professional. This unit of study will focus on clinical trial design from human phase I studies through to late phase trials. We will introduce, examine and critique clinical trial design features and concepts such as selecting the right patient population, randomisation and blinding, concepts of internal and external validity, defining study endpoints and choosing appropriate outcome measures. Students will also gain insight into how clinical trial questions are formulated from initial concept through to the development of a clinical trial protocol. Throughout this unit of study students will be exposed to a number of clinical trial design case studies, including those testing both pharmacologic and non-pharmacologic interventions.
Student assessment (100%) conducted throughout the semester, as advised within the relevant unit of study outline