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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:  1 December 2014
Working with states, territories and other stakeholders on a nationally consistent approach to clinical trials
Summary Activity Progress
Research Governance consultation 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.

A report of the outcomes of the consultation has been published on the NHMRC website. NHMRC is now incorporating changes to the process and will then conduct pilot studies to test the implementability of the process.

Revised list of clinical trial standard items consultation 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. NHMRC is incorporating changes to the list following consultation.
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).

A report of the outcomes of the consultation has been published on the NHMRC website. Following the consultation, NHMRC will continue development of the form.

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). Engagement of a consultant to conduct the feasibility assessment is in progress.
Safety reporting and monitoring - New NHMRC has engaged a consultant to develop a framework for safety reporting and monitoring of clinical trials. This work will be completed by March 2015.
Alltrials - New NHMRC has provided a statement in support of the Alltrials campaign. This statement has been published on  the NHMRC website.
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. The modules will be available in December 2014.
Support for clinical trials networks NHMRC are providing support for clinical trials networks to improve national co-ordination and communication within and across networks. This includes:
  • 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.
  • Working with ACTA to develop competencies for academic clinical trialists.




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 - New 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. NHMRC has established a steering group and commenced meetings to provide advice on refinements to the website and 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.

 

Page last updated on 1 December 2014