What is a clinical trial?
Southern Cross University has adopted the World Health Organization (WHO) definition of a clinical trial as:
“Any research study that prospectively assigns human participants or groups of humans to one or more health-related interventions to evaluate the effects on health outcomes.”
Research that introduces a change for participants, such as: a training program; behavioural intervention; education initiative; exercise program; digital tool; model of care; or clinical procedure, may meet this definition.
Important note about “small studies”
The size of the study (pilot, small n, researcher-led, or student project) does not determine whether it is a clinical trial. What matters is whether participants are prospectively assigned to a health-related intervention to evaluate effects on health outcomes.
What counts as a health-related intervention?
A health-related intervention is anything introduced as part of the research to influence a health outcome. Examples include:
- Medicines
- Vaccines
- Biological products
- Herbal and natural supplements or products
- Devices
- Surgical procedures
- Psychotherapeutic and behavioural treatments
- Dietary interventions
- Exercise programs
- Education programs
- Diagnostic strategies
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Process-of-care and system changes, including:
- Health-related preventative care strategies
- Health-related education interventions
- Delivery system changes (e.g., telehealth or online tools)
What counts as a health outcome?
Health outcomes are biomedical or health-related measures used to evaluate the effect of an intervention. Examples include:
- Physiological, biological, or psychological measures
- Changes in symptoms
- Disease progression or remission
- Health-related behaviours
- Quality of life
- Pharmacokinetic or pharmacodynamic measures
- Safety outcomes (including adverse events)
Use this tool to determine whether your project meets the definition of a clinical trial and, if so, what additional steps may be required.