Clinical Drug Studies
Protecting the rights, safety and wellbeing of clinical trial participants through independent ethical review of clinical drug trials.
Clinical drug trials
A clinical trial is a research study designed to assess the safety and/or effectiveness of a therapeutic intervention. In trials regulated by the TGA, “research” refers to the use of an unapproved therapeutic product. A clinical trial intervention may be a new treatment such as a drug, (or device), or other type of interventions such as diagnostic tools or procedures.
When participants are given a therapeutic intervention to evaluate its safety and/or efficacy, the research must include objectives measures, meaning the outcomes cannot be based on subjective interpretation. Generally, a control group is used to determine the effect of an intervention, for example, one group is given the new experimental drug, another group is given the standard care treatment or a placebo. A placebo is a copy of the study intervention that does not contain any active drug.
The clinical investigations pathway for medical devices is different to the clinical trial pathway for medicines. Find out further information about medical device trials.
Learn MoreWhat is an interventional drug product?
Any product that is not a registered good on the Australian Register of Therapeutic Goods or is being used for a different therapeutic area than what it is registered for.
Examples are new experimental drugs, cell therapies, biological products, vaccines and radiopharmaceuticals.
What are the phases of clinical trials for drugs?
These are early clinical investigations typically involving a small number of participants who may be healthy volunteers or patients.
The focus is to assess pharmacokinetics to determine the effect the drug has on the body and to assess safety and tolerability. Some phase I studies have two sub-phases.
• Phase Ia: Single ascending dose
• Phase Ib: Multiple ascending dose
May recruit a larger number of patients, focus is on efficacy and safety.
Phase IIa
• demonstrate clinical efficacy or biological activity
• explore therapeutic dose range
Phase IIb
• determine optimum therapeutic dose and regimen
• resolve uncertainties regarding the design and conduct of subsequent trials
A larger group of patients are recruited (300 to 3,000). The focus is efficacy or effectiveness.
Phase IIIa
• determine the therapeutic effect in patient populations for which the drug is eventually intended
• provide a definitive assessment of risk-benefit balance (to support drug registration or change in clinical practice)
Phase IIIb
• increase patient exposure and support marketing claims or publication.
A trial conducted after the product has been registered with the TGA and is being prescribed in a real-world setting (commonly known as post-marketing study). The focus is surveillance and/or resolution of treatment uncertainties. These trials monitor safety in real world populations to detect rare or long-term adverse effects and drug interactions.
Monitoring requirements
The NHMRC sets out the requirements for monitoring and reporting of safety events and serious breaches for clinical trials conducted in Australia.
Monitoring and reporting of safety events: NHMRC Safety Monitoring and Reporting in Clinical Trials (2016) and Bellberry guidance Safety Reporting.
Monitoring and reporting of serious breaches: Reporting of Serious Breaches of Good Clinical Practice (GCP) or the Protocol for Trials Involving Therapeutic Goods and Bellberry guidance Serious Breaches.
Get answers to common queries
Whether you’re preparing your first submission or managing amendments, these answers cover the most common scenarios and link to detailed guidance when needed.
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Not all projects require HREC review. Studies with more than a low level of risk must be reviewed by an HREC. Some low-risk or quality assurance activities may follow other pathways or be exempt. Refer to the National Statement on Ethical Conduct in Human Research for details, or see our Review Pathways guide.
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Still have questions? We’re here to help.
Browse our FAQs page or contact us for helpful guidance and detailed information.
How to Apply
Understand the full application process from start to finish. This step-by-step guide shows you how to register, prepare documents, and submit your study for review.
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Guidance & Resources
Find policies, templates, and checklists to support your application. From pre-submission planning to post-approval monitoring, this hub gives you practical tools at every stage.
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Our Fees
Review the current schedule of fees for new applications, amendments, and multi-centre studies. Transparent pricing helps you plan and budget with confidence.
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Ready to start or need advice?
If you’d like to speak with a Bellberry team member about your study or need help preparing an application, our customer service specialists are here to assist.
