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NHMRC

Clinical Trials

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.

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.

NHMRC’s progress to improve clinical trials in Australia

DATE OF LAST UPDATE:  3 November 2014
Working with states, territories and other stakeholders on a nationally consistent approach to clinical trials
Summary Activity Progress
Review of laws and Regulations - New NHMRC undertook a review of laws, regulations and mandatory standard operating procedures that apply to the ethical review and site assessment of human research. This review is complete. The table of laws and regulations has been published on the NHMRC Human Research Ethics Portal.
Review of insurance and indemnity arrangements NHMRC undertook a review of insurance and indemnity arrangements to identify any associated barriers to acceptance of these arrangements that may impact on the adoption of a nationally consistent process for clinical trial research. This review is complete. The review is available under NHMRC Clinical Trials Initiatives.
Research Governance consultation - New Following a clinical trial research governance forum, held in September 2013, and a research governance workshop, held in December 2013, NHMRC engaged HealthConsult to undertake a targeted consultation on a ‘Good Practice Process’ for the site assessment and site authorisation phases of clinical trials research governance.

This targeted consultation is complete.

A report of the outcomes of the consultation has been published on the NHMRC website.

Revised list of clinical trial standard items consultation - New NHMRC engaged HealthConsult to undertake a targeted consultation to develop a revised list of standard items for clinical trials. This revised list will be provided to the Independent Hospital Pricing Authority for costing and, ultimately, replace the existing costed list of standard clinical trial items. The report from the consultation including the draft list has been published on the NHMRC website.
Human Research Application Form consultation NHMRC has commenced work to develop 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). This targeted consultation is complete.

A report of the outcomes of the consultation has been published on the NHMRC website.

HRAF IT requirements NHMRC is currently looking at the IT requirements and design for the HRAF. The development of a design document for the IT solution to the HRAF was completed in July 2014.
Streamlining Ethical Review 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). Preliminary work has commenced, with NHMRC to first agree on the core questions and issues to be addressed via the consultation(s).
NHMRC certified HREC Chairs Forum NHMRC is engaging with the Chairs of certified HRECs to explore issues around the ethics review of clinical trials. The Forum was held on 22 September 2014.
Training and education for clinical researchers and support staff in industry and academia
Summary Activity Progress
Develop learning modules NHMRC is developing eLearning modules to provide an introductory understanding of the nature and importance of clinical trials, including ethics review and research governance. The modules are being developed and will be available by the end of 2014.
Support for clinical trials networks  - New NHMRC are providing support for clinical trials networks to improve national co-ordination and communication within and across networks. This includes:
  • Support for the Australian Clinical Trials Alliance (ACTA) to hold a summit of clinical trial networks in March 2014;
  • Support for ACTA to hold an International Symposium of clinical trial networks in 2015; and
  • Collection of information, through ACTA, on clinical trials networks including the volume of clinical trials and recruitment into these trials conducted by clinical trials networks and evidence on the contribution networks are making to the health system.

The report from the 2014 summit has been published on the NHMRC website.

 


This engagement will be completed in October 2014 and a report will be made available on the NHMRC website.

Clinical Trials Portal
Summary Activity Progress
Improve functionality of clinical trials website NHMRC is looking to improve the functionality of the Australian clinical trials website including improving the ability to search for clinical trials registered with the Australia and New Zealand Clinical Trials Registry (ANZCTR). NHMRC has commenced work with ANZCTR to improve functionality. The enhancements are due to be completed by December 2014.
Development of national interactive portal The Department of Industry, 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. The Department of Industry is preparing to consult on the core functionalities required of a clinical trials web portal. NHMRC will establish a steering group to provide advice on the functionalities of the portal.
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:
  • NHMRC will update the Department of Health on the progress of work to revise the list of standard clinical trial items.
  • Regular coordination meetings with the Department of Industry and Department on Health on progress delivering clinical trials reform.