Australia’s clinical trials environment is complex, with various responsibilities resting with institutions, private organisations and companies, State or Territory Governments and the Commonwealth Government.
Where clinical trials take place
Clinical trials usually take place in hospitals or other health sector organisations that are run by State and Territory Governments or by private institutions. These institutions are ultimately responsible for deciding whether clinical trials take place on their premises. Hospitals rely on advice from bodies such as HRECs on whether the proposed clinical trial complies with the principles of ethical behaviour set out in the National Statement on Ethical Conduct in Human Research (2007) – the ‘National Statement’.
Clinical Trials are initiated and organised by ‘sponsors’. Sponsors may include multi-national companies (e.g. pharmaceutical companies), small Australian companies, individual doctors or researchers, or the hospitals themselves. Sponsors are also responsible for notifying the Therapeutic Goods Administration (TGA) of any serious and unexpected adverse drugs reactions that occur during the trial, and other adverse reactions/events on request. Clinical investigators are required to obtain ethics approval for their research, notify the approving ethics committee and Sponsor of any adverse reactions/events and coordinate the conduct of the research across multiple sites.
Regulation of clinical trials in Australia
Clinical Trials in Australia are regulated at a number of levels under both Commonwealth and state and territory legislation.
At a Commonwealth level, the TGA, a division of the Commonwealth Department of Health, is responsible for regulating medicines and medical devices in a similar way to the Federal Drug Administration (‘FDA’) in the United States.
The TGA oversees the inclusion of medicines and medical devices on the Australian Register of Therapeutic Goods (ARTG). Generally, medicines or medical devices for human use that are imported, manufactured in Australia, supplied by a corporation, supplied interstate or to the Commonwealth, or exported must be included in the ARTG, unless exempted. Unapproved medicines and medical devices to be supplied in a clinical trial would require an exemption under the Clinical Trial Notification Scheme (CTN) or through the Clinical Trial Exemption Scheme (CTX).
Information on the CTN and CTX Schemes is available on the TGA website.
National laws governing the use and sale of new medicines and medical devices are supported by State and Territory laws that prohibit the possession of certain types of medicines without permission.
Ethics review of clinical trials
Proposals for ethical approval of clinical trials are assed by HRECs. Under the National Approach to Single Ethical Review, the NHMRC has certified the ethical review processes of 45 institutions, representing 49 HRECs. Many of these, because of their expertise, have been certified to assess applications for clinical trials. For further information on which HRECs are certified by NHMRC, visit NHMRC’s Human Research Ethics Portal.