Blog

Clinical Trials in Australia

The Australian clinical trial industry is large and growing fast. Roughly 1,360 new clinical trials were conducted in Australia in 2015, and since 2010, this number has grown at approximately 5 percent per year, which is faster than the growth in US, UK, and the global average. Investment in active clinical trials accounted for gross expenditure of about $1.1 billion in 2015. This includes about $930 million invested by industry players, most of whom are multinational medical devices, biotechnology and pharmaceutical companies that decided to invest in Australia. In 2015, the Australian clinical trials sector supported at least 6,900 highly qualified jobs

• Australia’s clinical trials are regulated at both the federal and state level. Of major significance are the TGA acts and regulations, the Australian Code for Responsible Conduct of Human Research and Australian Privacy Laws, the GCP documents (ICH GCP Guidance Annotated for Australia and the National Statement on Ethical Conduct in Research Involving Humans).
• Clinical trials are often conducted in hospitals, research centers, research institutes, or other health sector organizations run by governments of state and territory or private institutions.
• Australia allows clinical trials to be conducted by international healthcare organisations and research groups. An Australian entity must sponsor the trials. The entity can be a person, a hospital, an institution, or other company or organization. The sponsor assumes total responsibility for the trial’s conduct. For instance, the sponsor is fully responsible for designing the clinical trial and analyzing its data, assess safety on an ongoing basis and report adverse events.
• Agreement on provisions for insurance and compensation is a crucial step in the approval pathway for clinical trials. Indemnity and insurance requirements vary based on whether the clinical trial is being undertaken in the public or private sector and in which state or territory of Australia. Generally speaking, if the sponsor is a commercial company, the trial authorization largely depends on the company providing compensation plus evidence that adequate insurance arrangements cover it.
• Under the CTN Scheme (assessed by an HREC and notified to TGA as described above), several “unapproved” therapeutic products procured for clinical trials are approved. However, under another scheme, the CTX Scheme, which requires evaluation by TGA, the HREC (or a sponsor) may require review. The deciding factor is whether adequate scientific and technical data and competence to evaluate product safety are available to the HREC.
• When conducting clinical trials, it is crucial to have sufficient privacy arrangements in place, especially when medical data is sent internationally.

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