Introduction to clinical trials

Successful clinical research is conducted with a well-constructed study question that is feasible, interesting, novel, ethical and relevant. A study design must be conceived with appropriate measures of clinical observation and intervention. This unit will establish a fundamental knowledge in several areas including: development of the intervention, designing a good protocol, conducting clinical trial studies, international conference on harmonisation good clinical practice (ICH-GCP) and delegation of responsibility and co-ordination. The unit provides instruction in the development of a clinical research question and creating a concise protocol that includes multiple components such as a literature review, study design, subject sampling and recruitment, instruments and other measurement approaches, sample size, consent forms, budget and timetable. The aim of the unit is to introduce you to the processes and regulations involved in taking a proposed therapeutic through to clinical trials. Students completing this unit should be able to construct a testable clinical research question and design a protocol that is ethical, well controlled, and statistically powerful. You should also be able to identify the roles of the sponsor, the investigator, the institutional review board/ independent ethics committee and the local regulators.