Advantages of Conducting Clinical Trials in Australia
Cost – In comparison to US and Europe, Australia is 30% lower in study budgets. If R&D tax incentives are applicable, the cost advantage climbs to over 50%.
Incentives – Australia has the highest tax incentive for medical research and clinical trials in the world. Australia offers a generous 43.5% cash refund for clinical trials conducted in Australia if the applying country has a global revenue of less than 20M AUD.
Investigational New Drug (IND) not a pre-requisite – One of the major advantages of conducting clinical trials in Australia is that there is no need for an approved US FDA IND for initiating clinical studies. Clinical studies can be initiated in Australia at any time before or during the IND application process and then the data from these studies supplemented to the application, thus leading to a tremendous advantage of saved time. We have witnessed companies advancing directly in to Phase II at the time of IND approval since all Phase I studies were completed in Australia by the time IND approval was secured. This has been possible due to confidence in the very high quality of data generated for clinical studies in Australia.
Quick start-up – Another critical advantage of Australia is its regulatory framework for conducting clinical trials. Australia utilizes the Clinical Trial Notification (CTN) scheme for approving clinical trials. Under this scheme, the Australian regulatory Agency, Therapeutics Goods Administration (TGA), has delegated clinical trial review process to approved ethics committees (ECs). TGA only needs to be notified once approval is granted and before the initiation of the clinical trial. ECs in Australia have a comprehensive offering of services and maintain a very thorough review process. This process takes only 4-6 weeks for most clinical studies and thus saves precious time to get the trial started.
Intellectual Property (IP) Protection – Australia has one of the most stringent IP protection laws in the world. Australia is also a signatory to several international agreements that protect IP in other countries.