For sponsors
Conducting clinical trials in Australia
The regulatory pathway, government support for clinical research, and the factors sponsors should consider.
- R&D incentives
- Among the world's best
- Regulatory pathway
- CTN notification
- Ethics review
- ~4–6 weeks
- Trial data
- FDA & EMA accepted
01 / Tax
Government support for clinical research
What is available, who can access it, and where to obtain advice.
Australia provides some of the world's most competitive government support for research and development, and this is a principal reason sponsors place clinical trials here. Eligible companies may claim a refundable benefit on qualifying trial expenditure, payable as cash where the company is in a tax loss position — a position that applies to most clinical-stage companies.
Eligibility depends on the company's structure, residency and turnover, and on registration of the research activities with the relevant authority within the prescribed period. Overseas-owned groups commonly incorporate an Australian subsidiary to conduct the trial. Rates, thresholds and eligibility criteria are set by legislation and are subject to change, and sponsors should confirm the current position before modelling a programme.
Vitalis does not provide tax advice and sponsors should obtain their own from a qualified adviser. What the site does provide is trial documentation, invoicing and activity records maintained in a form that allows a sponsor's adviser to substantiate a claim without reconstructing the record afterwards.
02 / Regulatory
The CTN scheme
How clinical trials are authorised in Australia.
Most clinical trials in Australia run under the Clinical Trial Notification scheme. Under CTN, the scientific and ethical review is done by a Human Research Ethics Committee, and the trial is authorised at the site by the institution's approving authority. The sponsor then notifies the Therapeutic Goods Administration that the trial is occurring. The TGA does not review the trial data before it starts.
In practice, the critical path for start-up is the HREC meeting calendar rather than a regulatory review period. Most committees meet monthly and issue a single round of queries; approval commonly follows within approximately four to six weeks of submission where the package is complete. A trial may commence once ethics approval, site authorisation and the notification are all in place.
A smaller number of trials proceed under the Clinical Trial Approval pathway, which does involve review by the TGA. Whether a product falls within that category should be established before planning to CTN timelines, and is assessed by the site at feasibility.
03 / Data
Data acceptance and considerations
Advantages
Trials conducted to ICH E6(R3) in Australia are routinely included in FDA and EMA submissions. The population is genetically diverse and comparable to other Western populations. Southern-hemisphere seasonality offers an advantage for respiratory and vaccine studies, with a season six months out of phase with the northern hemisphere — Melbourne's respiratory season typically runs from late autumn through winter.
Considerations
Per-participant costs in Australia are not the lowest available. Government R&D incentives are a material component of the overall cost position, and sponsors unable to access them should model accordingly. Studies in rare indications may recruit more slowly than in larger markets. The CTN pathway removes a regulatory review period but not the requirement for a complete and well-prepared ethics submission.
Assess the pathway for your programme
The site will model start-up against your target first-dose date.