Public consultation underway to boost the clinical trials sector

Reforms are underway to boost Australia’s clinical trials sector and attract more clinical trials – giving Australian patients increased access to potentially life-saving treatments and medications.

To promote Australia’s reputation in clinical trials research, a national consultation process is now underway to develop the National Clinical Trials Governance Framework. The Framework will support the integration of clinical trials service provision into routine hospital care and reinforce Australia’s standing as one of the world’s leaders in medical research.

Consultations began on 6 February 2019, with a series of stakeholder workshops to be held across all states and territories until 22 March 2019. Development of the framework is being led by the Australian Commission on Safety and Quality in Health Care (the Commission), which was engaged by the Australian Government Department of Health on behalf of all jurisdictions to deliver the Framework by mid-2019.

The Commission’s work is a key element of a clinical trials agenda endorsed by all Health Ministers in March 2017, and supports related national clinical trials efforts underway including the Encouraging More Clinical Trials in Australia budget measure.i The initiative is driving reforms nationally to improve efficiencies, better engage sponsors and improve trial start-up times – with the ultimate aim of growing the number of clinical trials conducted in Australia.

The nation’s Chief Medical Officer, Professor Brendan Murphy, said boosting cohesion and productivity across the clinical trials sector would benefit both Australian patients and the health sector.

“Australia has a world-class reputation for conducting excellent research through clinical trials. The Clinical Trials Governance Framework is the first step toward accrediting health services undertaking clinical trials.

“Our high-quality clinical trial sites have been attracting companies from across the globe for over three decades. To build on this success, Australia must build on its reputation for quality trials and reduce the variation between sites. The Framework will position Australia to be a preferred destination for clinical trials,” said Professor Murphy.

Commission Chair, Professor Villis Marshall AC, said Australian patients will benefit from better outcomes due to these reforms. Australians are keen to be involved in clinical trials, and research provides access to cutting edge treatments and interventions of the future.

“The revitalisation of the clinical trials environment also supports the wider medical sector. Researchers will gain global recognition for their work and improve their technical skills, while industry will thrive from rising international R&D expenditure and the decline in the so-called ‘brain drain’ of highly qualified Australian researchers seeking opportunities overseas,” said Professor Marshall.

Clinical trials are undertaken in a number of therapeutic areas in Australia, including: oncology, respiratory, central nervous system, infectious disease, metabolic disorders, cardiovascular, aged care and mental health.

Examples of recent successes of Australia’s collaboration in research with global pharmaceutical companies have resulted in the development of Gardasil, a vaccine against human papillomavirus and Relenza, the first effective drug to treat all strains of influenza.ii

Consultation on the Governance Framework is open to key organisations and individuals with an interest in or working in the clinical trials sector. The Governance Framework and high-level implementation strategy will be released later this year.

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About the Commission

The Australian Commission on Safety and Quality in Health Care is an Australian Government agency that leads and coordinates national improvements in the safety and quality of health care based on the best available evidence. By working in partnership with the Australian Government, states and territories, the private sector, clinical experts, and patients and carers, the Commission aims to ensure that the health system is better informed, supported and organised to deliver safe and high-quality care.



i. Budget 2017-18, Budget Overview, Australian Government

ii. Clinical Trials Capability Report, Australian Trade and Investment Commission, January 2018, p.6