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International and Australian research sponsors can develop and support the highest quality clinical trials and benefit from the advantages of the Australian clinical trials environment, including top-rated facilities and researchers, efficient review and regulatory frameworks and financial incentives.
The resources on this site are designed to assist with this process by providing information and guidance.
Sponsors are also encouraged to review the information contained in the section Clinical trial information for researchers on this website.
Metro South Health has many advantages as a place to conduct clinical trials. This is because Metro South Health and the Translational Research Institute (TRI) is home to some of the world's best researchers and health professionals and boasts a world-class research infrastructure, a stable socio-political environment, and high standards that ensure confidence in the scientific conclusions reached by clinical trials conducted in Australia.
Metro South Health has a robust Intellectual Property (IP) system and a simple and efficient regulatory regime. These are all factors that have contributed to the strong growth of investment in clinical trials in Metro South Health by global biopharmaceutical and medical technology companies over the past three decades.
International standards of conduct for clinical trials, developed by the International Conference on Harmonisation (ICH) and the International Organization for Standardization (ISO), provide a benchmark of clinical research quality that can be relied upon throughout the world. Under the Therapeutic Goods Act 1989 and associated regulations, ICH or ISO Good Clinical Practice (GCP) standards are mandatory for all Australian clinical trials involving unapproved medicines or medical devices. Many Australian researchers have international experience and are familiar with GCP and other guidelines.
Australia adheres to the highest level of GCP standards, meaning that Australian clinical data and results are accepted by international regulatory agencies, including the United States Food and Drug Administration and European Medicines Agency.
The Australian Therapeutic Goods Administration (TGA) has adopted the European Guideline CPMP/ICH/135/95 (and therefore the ICH E6 guidance) in principle, with some elements modified according to local regulatory requirements (see Note for guidance on good clinical practice).
Australia has a fast and pragmatic regulatory pathway for clinical trials. Under the Clinical Trials Notification (CTN) scheme administered by the TGA, research proposals are submitted directly to certified Human Research Ethics Committees (HRECs) which assume the primary review responsibility for ethical and scientific review.
Metro South Health operates an extremely efficient HREC.
Metro South Health has adopted the streamlined ethical clearance process for multi-centre research that helps to reduce unnecessary duplication of review of research.
Metro South Health has an informed and willing population of potential trial participants, resulting in a higher level of research participation than would be expected from a population of our size. Australia is a multi-cultural country with a diverse population that is capable of meeting recruitment needs.
Metro South Health clinical practices and some aspects of our health care system are similar to the United States, United Kingdom and most of Europe.
The Australian Government’s generous Research & Development (R&D) Tax Incentive encourages more industry investment in R&D.
The Incentive provides businesses investing in eligible R&D with generous tax offsets:
Other benefits under the new R&D Tax Incentive include:
Above all, the new system provides a globally competitive tax incentive for conducting R&D activities in Australia.
The seasonal differences between the Northern and Southern hemispheres allows trials dependent on seasonal factors (eg flu vaccine, allergy or respiratory ailments trials) to be conducted or continued in Australia, extending the appropriate period for patient/participant recruitment.
Queensland also offers increase instances of skin cancer a melanoma due to our seasons and lifestyles.
The Australian Government is committed to improving the clinical trials environment in Australia. More details on the initiatives that will improve the clinical trials environment, along with their progress are available on the Australian Government Clinical Trials Initiatives webpage.