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Clinical trials are essential for evaluating the effectiveness and safety of drugs, devices, services and interventions to help prevent, detect or treat illness and disease. It is through the research done in clinical trials that people gain access to better treatments sooner. Clinical trials also bring hundreds of millions of dollars each year into the Australian economy.

All clinical trials in Australia are assessed and monitored by Human Research Ethics Committees (HRECs).

While the pharmaceutical and biotechnology industries sponsor many of the clinical trials in Australia, there are many that are initiated by researchers and health professionals. NHMRC often funds these types of trials. NHMRC, the Department of Industry, and Department of Health are working together to achieve a nationally consistent approach to the way that clinical trials are conducted, to help promote education and training, and to make it easier for patients to enrol in clinical trials.

If you would like more information on clinical trials in Australia, including those currently underway, visit the Australian Clinical Trials website.

Further information on clinical trials can be found in the ‘Consumer Guide to Clinical Trials’ fact sheet (PDF, 457KB).

The Australian Clinical Trials Environment

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.

More information on the Australian Clinical Trials Environment

Australian Government Clinical Trials Initiatives

NHMRC, the Department of Health and the Department of Industry are working together and with other States and Territories to improve the clinical trials environment in Australia and to achieve a nationally consistent approach to the way that clinical trials are conducted, to help promote education and training, and to make it easier for patients to enrol in clinical trials.

More information on NHMRC Clinical Trials Initiatives
A combined update on all clinical trials initiatives is available on the Australian Clinical Trials website.

NHMRC’s progress to improve clinical trials in Australia

Working with states, territories and other stakeholders on a nationally consistent approach to clinical trials
DATE OF LAST UPDATE: 2 March 2015
Summary	Activity	Progress
Streamlining Research Governance - New	Following extensive consultation, NHMRC has developed a ‘Good Practice Process’ (The Process) for the site assessment and site authorisation phases of clinical trials research governance.	NHMRC is working with the Research Governance working group to finalise the Process. NHMRC is asking pilot sites to test the Process.
Human Research Application Form - New	NHMRC is developing a common human research application form. NHMRC engaged Roxsolt Ltd to undertake a targeted consultation on the structure and content of a new Human Research Application Form (HRAF). A report of the outcomes of the consultation has been published on the NHMRC website.	NHMRC is now progressing development of the content in consultation with the HRAF advisory group. NHMRC has issued a request for tender to develop a proof of concept and subsequent build for the IT solution for the form.
Streamlining Ethical Review - New	In 2014-15, NHMRC will engage consultants to advise on the feasibility of, and the framework, criteria and process for, credentialing a small number of national ‘clinical trial’ Human Research Ethics Committees (HRECs).	NHMRC engaged a consultant to conduct a targeted consultation to assess the feasibility of credentialing a small number of HRECs to consider reviews of clinical trials applications. The consultation has now closed.
Safety reporting and monitoring - New	NHMRC has engaged a consultant to develop a framework for safety reporting and monitoring of clinical trials.	The consultant is conducting a targeted consultation with key stakeholders. This consultation closes on 6 March.
Training and education for clinical researchers and support staff in industry and academia
Summary	Activity	Progress
Develop learning modules	NHMRC has developed eLearning modules to provide an introductory understanding of the nature and importance of clinical trials, including ethics review and research governance.	COMPLETED The modules are now available on the www.australianclinicaltrials.gov.au in website.
Support for clinical trials networks	NHMRC are conducting a number of activities to support clinical trials networks to improve national co-ordination and communication within and across networks. These include:
	Providing support for the Australian Clinical Trials Alliance (ACTA) to hold an International Symposium of clinical trial networks in October 2015; and
	Through the work of ACTA, collecting information on the activity of clinical trials networks including the number of clinical trials conducted by networks and recruitment into these trials , and on the contribution networks are making to the health system.	Supported by NHMRC, ACTA is collecting information on clinical trials networks including the contribution of clinical trial networks to the health system. This will be provided by end of April 2015. Information will be made available on the NHMRC website
Development of competencies for academic clinical trialists	NHMRC will work with ACTA to develop competencies for academic clinical trialists.	With the assistance of ACTA, NHMRC will hold a workshop to develop draft competencies. This will be held in early 2015.
Clinical Trials Portal
Summary	Activity	Progress
Improve functionality of clinical trials website -	NHMRC is improving the functionality of the Australian clinical trials website by improving the ability to search for clinical trials registered with the Australia and New Zealand Clinical Trials Registry (ANZCTR).	COMPLETED. The search function is now available.
	NHMRC is working through ways to further enhance the usability of the website.	NHMRC has commenced work to enable the website to be read more easily on mobile devices.
Development of national interactive portal	The Department of Industry and Science, assisted by NHMRC, is working to expand the functionality of the website to ultimately develop an interactive portal to streamline the administrative process and further boost participant recruitment.	NHMRC has established a portal steering group and commenced meetings to provide advice on refinements to the website and the functionalities of the portal.
Engagement with Stakeholders
NHMRC engages with stakeholders in numerous clinical trials reform activities - New
Reporting
NHMRC provides updates to the Clinical Trials Advisory Committee (CTAC) on the progress of work under the initiative. NHMRC provides updates to the States and Territories through a variety of forums, including: Through the Commonwealth, provides updates to State and Territory Ministers and Directors-General of Health through the COAG Standing Council on Health (SCoH), the Australian Health Ministers’ Advisory Committee (AHMAC), the Hospitals Principal Committee (HPC) and the Clinical Trials Jurisdictional Working Group of the HPC. Regular coordination meetings with the Department of Industry and Science and Department on Health on progress delivering clinical trials reform.

Page last updated on 3 March 2015