Australia has the reputation of being home to a world-class research infrastructure with renowned health professionals and researchers overseeing clinical trials.
All Australian clinical trials have to follow strict guidelines set by multiple regulatory bodies, including the Human Research Ethics Committee (HRECS) and the Therapeutic Goods Administration (TGA), and have to prove that they adhere to Good Clinical Practice (GCP) standards.
Over the years, the international health and research industry has come to expect valuable data from Australian clinical trials.
Benefits of Australian Clinical Trials
- Government Support & Initiatives: The State and Federal government of Australia has committed to supporting clinical trials by introducing reforms which make Australia an ideal place for clinical trials. These reforms aim to speed up the waiting and approval time for trials, increase participation and reduce the cost of clinical trials in Australia. The Medical Research Future Fund (MRFF) was a reform established in 2015 and supports research projects.
- World-Class Research Infrastructure: Australia has a world-renowned research industry with some of the world’s best researchers and medical professionals conducting clinical trials.
- Strict Regulatory Guidelines and Laws: Australia’s clinical trials adhere to strict guidelines and ethical and safety laws which are set out by multiple regulatory bodies.
- Human Research Ethics Committee (HRECS): Follows the guidelines set out by the National Statement on Ethical Conduct in Human Research (written in 2007; updated in 2015) which is governed by The National Health and Medical Research Council (NHMRC).
- Therapeutic Goods Administration (TGA): Established in 1989 under the Therapeutic Goods Act 1989 and operates under the Australian Government Department of Health.
- Good Clinical Practice (GCP): An international standard which was established by the World Medical Association’s Declaration of Helsinki and is overseen by the TGA.
- State-Of-the-Art Research Facilities: Clinical trials take place in world-class facilities with access to the best equipment for testing, treatment and analysis.
- Efficient Approval Process: Australia operates under a streamlined approval process. Most clinical trials in Australia follow the Clinical Trial Notification scheme (CTN) in which all the relevant materials are sent off to be analysed by the Human Research Ethics Committee (HREC) so they can assess the scientific validity of the clinical trial and the safety of the participant, and the medical device or drugs being tested. Once the trial has been approved by the HREC, the Therapeutic Goods Administration (TGA) is notified and the trial can go ahead.
- Tax Incentives: The Australian government introduced the Research and Development (R&D) Tax Incentive in 2011 and aims to encourage further investment in research and development, increased access by international companies and an increased level of funding that can be claimed overseas when taking part in Australian research and development.
- Good Reputation: For over 30 years, the international medical and research industry have come to expect high-quality and reliable data from Australian clinical trials. Large international regulatory bodies like the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) often use the data collected from Australian clinical trials.
- Strong Intellectual Property System: Australia has one of the most secure intellectual property systems in the world, making it ideal for innovation and research. Some benefits include:
- Years of Protection: In accordance with Article 33 of The World Trade Organization’s Agreement on Trade-Related Aspects of Intellectual Rights, patent owners get 20 years of protection.
- Data Exclusivity for New Pharmaceutical Products: Five years of data exclusivity means that competitors can’t use efficiency data from the date the product is registered on the Australian Register of Therapeutic Goods.
- Innovation Patents: Innovation patents last up to 8 years and protect new medical devices/treatments and medications that do not meet the inventive threshold required for normal patents.
- Willing Participants: Multiple studies have shown that a large number of Australian citizens are informed and willing to participate in clinical trials. Its multicultural, diverse population also makes recruitment requirements easier to meet.