Units / PHI5236
PHI5236 · Clinical trials
2026 Handbook6 credit pointsLevel 5Department of Epidemiology and Preventive Medicine
Last checked: 23 Aug 2026 UTCOverview
Clinical trials provide the most robust evidence of the benefits of healthcare intervention and deemed as the 'gold standard' of study design. A solid understanding of clinical trials is a key requirement for researchers and clinical trial professionals working in clinical research, or health care practitioners who need to interpret and apply the results of clinical trials in their work. This unit will equip you with the skills to develop a sound clinical trial questions, design clinical trial protocols and consider issues of ethics, budget and quality assurance. It will also endow you with the skills to critically appraise clinical trials.
Areas of study: Public health
Offerings
| Campus | Teaching period | Mode |
|---|---|---|
| Indonesia | Monash Indonesia term 4 | Teaching activities are on-campus and in a block period (ON-BLK) |
Assessment
The Handbook does not list a final examination among the assessment items. That is not a guarantee there is none.
| # | Assessment | Type | Weight | Hurdle |
|---|---|---|---|---|
| 1 | Critical appraisal of RCT (Max. 12 pages A4, 1.5 spacing) | Written | 15% | — |
| 2 | Individual poster presentation of concept protocol (1 x page A0 - pdf file) | Artefact | 35% | — |
| 3 | Group presentation of draft study protocol (15 mins presentation with 10 mins feedback) | Presentation | 20% | — |
| 4 | Group presentation of final study protocol (15 mins presentation with 10 mins feedback) | Presentation | 30% | — |
Assessment details may change. Please refer to the assessment information in Moodle closer to the start of the teaching period.
Requisites
prohibitions
- MPH5236 — Clinical trials
Learning outcomes
- Examine the principles of clinical trials and understand their role in informing healthcare practice and policy.
- Critically analyse the theoretical approaches to clinical trials, including different types of clinical trials, and the strengths and limitations of each.
- Formulate a meaningful question that has relevance to clinical practice or public health, design the right trial for the question, and articulate this design in a study protocol.
- Critically appraise a published clinical trial in order to determine its validity or otherwise to real-life practice and policy.
- Explain the importance of communication between key stakeholders in clinical trials.
- Investigate the practical considerations of undertaking clinical trials, including planning, gaining ethics approval, recruitment and retention of subjects, measurement of outcomes and data analyses.
Workload
24 hours per week including directed and self-directed learning (scheduled classes, prescribed activities and independent work).
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