TRM6001 · Introduction to clinical trials

Overview

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.

Areas of study: Translational research

Offerings

Assessment

The Handbook does not list a final examination among the assessment items. That is not a guarantee there is none.

ICH-GCP Quizzes (10%) Clinical Trial Project (40%) Critical appraisal (1,500 words) (25%) Oral Presentation (20 mins) (25%)

Assessment details may change. Please refer to the assessment information in Moodle closer to the start of the teaching period.

Requisites

The Handbook lists no prerequisite, corequisite or prohibition for this unit.

Learning outcomes

1. Design a clinically relevant question and set of experiments.
2. Outline Good Clinical Practice as followed by the international Conference on Harmonisation.
3. Identify and describe the key steps in conducting a Clinical Trial including different types of human research and protocols that can be implemented.
4. Identify and describe the key steps in the drug discovery process including identification of drug targets, Australian regulatory requirements, manufacture, development of a safety profile, clinical development and marketing.
5. Outline how to manage regulatory documents.
6. Outline the role of the Sponsor, the investigator, the institutional review board/ independent ethics committee and the local regulators.
7. Critically review the literature and formulate clear and testable hypotheses for a specified clinical trial.

Workload

Approximately 12 hours of study per week distributed as: • Teacher-directed learning (online lectures and workshops) and Team-based learning (presentations and clinical trial project development or WIL placement). Approximately 6 hours per week (averaged across the semester). • Self-directed learning including private study time, critically evaluating published studies and clinical trial literature and completing assignments. Approximately 6 hours per week (averaged across the semester).

Student experience, not official rules. Nothing here changes what the Handbook says.