Each year more than 1,000 research projects are conducted in Australia by pharmaceutical, medical device, and biotechnology companies, spending more than US $1 billion on clinical trials. The case for Australia as a location in which to undertake clinical trials is compelling.
Why is Australia so attractive as a location for clinical investments? Key competitive attributes include:
- Australia’s globally recognised researchers and facilities
- Australia’s efficient ethics and simplified regulatory framework
- Australia’s diverse recruitment pool
- Australian government commitment to reduce time and cost
- Australia’s cost competitiveness.
Australia’s globally recognised researchers and facilities
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
Australia’s efficient ethics and simplified 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 four to eight 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.
Most commercially sponsored clinical trials in Australia are conducted under the Clinical Trial Notification (CTN) scheme, which reduces the regulatory burden on clinical trial sponsors. Under this scheme, all clinical trial materials, including the trial protocol, are submitted directly to the institutional ethics committees by researchers at the request of the relevant sponsor. The ethics committee is solely responsible for assessing the scientific validity of the trial design, the safety and efficacy of the medicine or device, the ethical acceptability of the trial process, and the approval of the trial protocol. The institution where the clinical trial is to be conducted gives the final site approval.
The Therapeutic Goods Administration (TGA), the Australian equivalent of the United States Food and Drug Administration (US FDA), is merely notified of a clinical trial after it has received site approval. The TGA does not review any data relating to the trial. However, the TGA has the authority to audit and enquire into the management of a clinical trial.
The CTN scheme eliminates the duplication of processes, enabling sponsors conducting clinical trials in Australia to save both time and money.
Australia’s diverse recruitment pool
Australia presents both 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.
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.
Australian Government commitment to reduce time and cost
Clinical trial reform is central to the Australian Government’s national macroeconomic reform agenda, underlining Australia’s ambition to remain one of the world’s leading destinations for clinical trials. In partnership with the principal stakeholders, the Australian Government is in the process of implementing a series of reforms to further minimize study start-up times, boost patient recruitment, and standardize clinical trial costs. Key initiatives include:
- Standardize clinical trial costs to streamline processes and save time: Plans are underway to publish standard costs for clinical trials to enable sponsors to draw up budgets and reduce individual sites’ contract negotiation times
- Improve coordination across states: The National Mutual Acceptance (NMA) program established in four key states accounts for 90% of clinical trial activity in Australia. The NMA will ensure mutual acceptance of scientific and ethical reviews for multi-centre clinical trials
- Build and enhance capability: The Australian Government has nationally accredited education and training courses for investigators and site personnel.
Australia’s cost competitiveness
Australia is highly cost-competitive in comparison to the US in the early phase clinical trials.
In a 2015 Frost & Sullivan Study US CROs were asked to estimate the cost of a standard early phase clinical trial (Phase 1) to be conducted in the US, while an Australian CRO was asked to price the same study using the same specifications and requirements
According to the cost comparison study, Australia was, at the time 28% cheaper than the US before tax incentives; and 60% cheaper after R&D Tax incentives.
Based on a lower value of the Australian Dollar today compared to 2015, this cost advantage is even more significant.
Contact us today for an obligation free discussion regarding your eligibility for the R&D Tax Incentive in Australia.