Why choose Australia?
Australia is home to some of the world’s best researchers and health professionals and boasts a
world-class research infrastructure, with a long and successful history of conducting clinical studies.
With one of the fastest regulatory pathways in the world, our ethnically diverse, English-speaking
population means Australia is an optimal selection for most clinical trial indications.
The impact of the COVID-19 pandemic on communities and individuals worldwide continues to
affect the way we live and work. In Australia, we have managed to keep our numbers relatively low,
with a total of 28,911 cases and 909 deaths since the pandemic began. Today we have only 42 cases
in the country, most of these being returned travellers in hotel quarantine. Although it is not quite
“business as usual” in Australia, we have been able to continue to run our clinical trials with minimal
Sophisticated Research Environment
Australia offers state-of-the-art translational facilities enabling bench to bedside research. There are multiple specialised phase I units which have supported a rapid growth in Phase I activity. Since 2008, Phase I activity in Australia has grown steadily, recording a 17.2% growth in volume from 2012–2015, compared with 1.8% growth globally. This reflects the advantages offered by specialised Phase I units in Australia1.
Healthcare infrastructure in Australia includes public and private hospitals and specialised research centres, all of which are well resourced and experienced in running Clinical Trials (Figure 1). This supports large multicentre phase III Clinical Trials. Australia also has an extensive privatised GP networks to support Clinical Trials in Primary Care.
Figure 1: Research Activity in Australia
Mature Ethics and Regulatory system
The ethical review process supports single centre, multi-centre and mutual acceptance between sites. Ethics committees are located in both the private and public sectors, with review timelines often shorter in the private sector. Submissions can be tailored to specific study requirements.
Materials relating to a proposed clinical trial, are submitted directly to institutional ethics committees. The ethics committee is solely responsible for assessing the scientific and ethical aspects of the trial and approving the trial protocol. The usual review cycle takes only 4 to 8 weeks, and is based on the submission of a protocol, investigator brochure and if required, an independent toxicology report.
The Clinical Trial Notification (CTN) scheme supports best practice in reducing the regulatory burden on clinical trial sponsors. Most clinical trials conducted in Australia are performed under the CTN scheme. Under the CTN scheme, the Therapeutic Goods Administration (TGA) is simply notified of a clinical trial and does not review any data relating to it, eliminating unnecessary duplication. This process usually takes up to 10 business and therefore research can start much sooner.
Australian clinical practices and some aspects of its health care system are similar to the United States, United Kingdom and most of Europe. In addition, the clinical data complies with the highest international standards ensuring confidence in the scientific conclusions reached by clinical trials conducted in Australia. These factors combined mean that Australian clinical trial data are accepted by the US Food and Drug Administration (FDA) as well as the European Medicines Agency (EMA).
The seasonal differences between the Northern and Southern hemispheres allows trials dependent on seasonal factors (e.g. flu vaccine, allergy or respiratory ailments trials) to be conducted or continued in Australia, extending the appropriate period for patient recruitment.
The Australian Government’s Research and development (R&D) tax incentive3 encourages companies to engage in R&D, by providing a tax offset for eligible R&D activities. This tax Incentive provides a globally competitive incentive for both home-grown and foreign-owned companies to conduct R&D activities in Australia.
Of note, there is no requirement for companies conducting R&D in Australia to demonstrate year-on-year growth in their R&D expenditure in order to claim a tax benefit. In addition, there is no requirement for intellectual property from eligible R&D projects to be held in Australia.
- Clinical Trials Capability Report, January 2018
- Australian Clinical Trials
- The Australian Government’s Research and development (R&D) taxincentive