The Austrade Industry Capability Report (Clinical Trials) points out Australia's distinct advantages as a place to conduct clinical trials.
The report features information on Australia’s transparent and effective regulatory system, its attractive Research and Development (R&D) Tax Incentive, intellectual property protection and reforms that are underway in clinical trials.
The new report can be found at the Austrade website.
Transparent and effective regulatory system
The high quality of Australia’s data standards for regulation is recognised and acceptable to key jurisdictions. Also, for over two decades, Australia’s Clinical Trial Notification (CTN) scheme has been a global benchmark for best practice in reducing the regulatory burden on clinical trial sponsors
Under the CTN Scheme, all materials relating to a proposed clinical trial, including the trial protocol, are submitted directly to institutional ethics committees, which are solely responsible for assessing the scientific validity of trial designs, the safety and efficacy of the medicine or device, the ethical acceptability of the trial process, and for the approval of the trial protocol.
The CTN scheme is designed to eliminate unnecessary duplication and saves sponsors that are conducting clinical trials in Australia a significant amount of time and money.
Attractive R&D Tax Incentive
The Federal Government’s R&D Tax Incentive is key in attracting many overseas companies to conduct clinical research in Australia. It is specially designed to make access to tax benefits more efficient and predictable, so as to encourage local in international companies to conduct R&D in Australia and recognises its inherent value.
Good IP protection
Australia has one of the strongest and most stable intellectual property (IP) systems in the world – ranking 11th in the world (out of 142 countries) on the International Property Rights Index.
CT reform
The Federal Government, in partnership with industry and other stakeholders, is now in the process of implementing a series of reforms to further reduce study start-up times, boost patient recruitment and standardise clinical trial costs – aiming to make Australia an even more attractive place to conduct clinical trials.
Initiatives include:
- The National Mutual Acceptance Program enables mutual acceptance of scientific and ethical reviews for clinical trials that occur across multiple sites. Four of the eight Australian states and territories, which together account for 90 per cent of clinical trial activity in Australia, currently participate in the Program.
- A list of standardised CT costs associated with conducting clinical trials in Australia is being developed by the Federal Government. The project, which is expected to be completed by the end of 2015, is to help sponsors to reliably predict the cost of conducting clinical trials in Australia and significantly reduce the time it takes them to negotiate contracts with individual sites.
- To boost skills, the Government has developed nationally accredited education and training courses for investigators and site personnel who prepare clinical trial applications and oversee the process for their approval.