Why conduct a clinical trial in Australia

Australia has many advantages as a place to conduct clinical trials. This is because Australia 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. Australia has a robust intellectual property 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 Australia by global biopharmaceutical and medical technology companies over the past three decades.

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High-quality research and facilities

Australia has a strong reputation for the quality of its scientific and medical research. Australia is internationally recognised for its highly trained clinical workforce and the high-quality data produced by its experienced, trained (and accredited) research teams. Australian clinical research sites also have high-quality clinical facilities with state-of-the-art equipment for testing, treatment and analysis. These characteristics of the Australian environment ensure high quality research conduct and generate confidence in the findings of clinical trials conducted in Australia.

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 US 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).

Efficient ethics and regulatory framework

Australia has a fast and pragmatic regulatory pathway for clinical trials. Under the Clinical Trials Notification (CTN) scheme administered by the Therapeutic Goods Administration (TGA), research proposals are submitted directly to Australian human research ethics committees (HRECs) which assume the primary review responsibility for ethical and scientific review. The usual review cycle takes only 4 to 8 weeks and is based on the submission of a protocol, investigator brochure and if required, an independent toxicology report. This effective and efficient process avoids costly preparation of extensive regulatory applications and means that research can start much sooner.

The TGA also administers the Clinical Trials Exemption (CTX) scheme, under which proposals are submitted to the TGA for scientific review followed by ethical review conducted by the HREC.

Australia has developed ethics review processes for multi-centre research that help to reduce unnecessary duplication of review of research.

Diverse participant recruitment pool

Australia 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 multicultural country with a diverse population that is capable of meeting recruitment needs. Recommendations by the Clinical Trials Action Group, including the development of this website — www.australianclinicaltrials.gov.au — are helping to improve awareness and support patient recruitment.

Australian treatment processes and regimens are often similar to the United States, Canada and some western European countries.  Australia’s diverse population enables recruitment of a similar patient population to recruitment in those countries.

In addition, the Australian Institute of Health and Welfare collects statistics on Australian risk factors, diseases and death in Australia, and provides links to online data collections, which also provides useful information for sponsors considering placing trials in Australia.

Investment incentives

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:

  • a 45 per cent refundable R&D tax offset (equivalent to 45c per $1 of eligible R&D) for companies with aggregated annual turnover of less than A$20 million; and
  • a 40 per cent non-refundable R&D tax offset (equivalent to 40c per $1 of eligible R&D) for all other eligible companies.

Other benefits under the new R&D Tax Incentive include:

  • Clinical trials can be eligible R&D activities under the program and are considered for eligibility under the same rules as any other activity;
  • The Incentive provides for increased access by international companies. In particular, there is no requirement to hold the intellectual property in Australia;
  • Certainty and stability of the rate of support to companies as the rates are no longer linked to the company tax rate;
  • Increased level of expenditure that can be claimed on R&D activities undertaken overseas in support of Australian R&D projects, under certain conditions.

Above all, the new system provides a globally competitive tax incentive for conducting R&D activities in Australia.  More information about the R&D Tax Incentive can be found at www.business.gov.au.

Health care environment

Australian clinical practices and some aspects of its health care system are similar to the United States, United Kingdom and most of Europe.

Seasonal differences

The seasonal differences between the Northern and Southern hemispheres allows trials dependent on seasonal factors (e.g. flu vaccine, allergy or respiratory ailments trials) to be conducted or continued in Australia, extending the appropriate period for patient recruitment.

Government commitment to clinical trials

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 here.