- The National Approach
- HREC meeting dates
The Clinical Trials Action Group (CTAG) was formed in October 2009 by Senator the Hon Kim Carr, Minister for Innovation, Industry, Science and Research, and the Hon Nicola Roxon, MP, Minister for Health and Ageing.
CTAG was established in response to the Pharmaceutical Industry Strategy Group Final Report to identify and progress necessary reforms to secure Australia’s competitiveness in the clinical trials sector.
CTAG was co-chaired by the Hon Richard Marles MP, the then Parliamentary Secretary for Innovation and Industry and the Hon Mark Butler MP, the then Parliamentary Secretary for Health.
Other members of CTAG were Professor Jim Bishop AO, the then Australian Government Chief Medical Officer, Dr Timothy Dyke, Executive Director, the National Health Medical Research Council (NHMRC) and Mr Mitch Kirkman of Novartis Pharmaceuticals Australia Pty Ltd.
The CTAG report Clinically Competitive: Boosting the Business of Clinical Trials In Australia was released by Ministers Carr and Roxon on behalf of the Australian Government on 3 March 2011.
In releasing the report, the Ministers acknowledged the alignment of the recommendations with the Government’s broader health reform agenda and noted the importance of maintaining competitiveness and secure investment in clinical research in order to ensure that Australians continue to enjoy the benefits that clinical trials can provide to the health system.
The Ministers noted in their press release that “Clinical trials help patients benefit from the latest treatments available, which ultimately lead to better health outcomes for all Australians. The press release can be found at:
The CTAG report makes 11 recommendations, all of which were accepted by the Government. Implementation of the recommendations will lead to improved productivity and benefit patients, industry, researchers and governments.
The CTAG report and further information about the CTAG process can be found at:
Recommendation A of the CTAG Report relates directly to the NHMRC’s Harmonisation of Multi-centre Ethical Review (HoMER) initiative and the national approach to single ethical review (National Approach).
Under the Harmonisation of Multi-centre Ethical Review (HoMER) initiative, NHMRC has completed a suite of documents, tools and advice to support the National Approach. This includes:
In response to Recommendation B, NHMRC has written to the Deputy Vice-Chancellors (Research) of all Australian Universities; and the CEOs of Private Health Providers to encourage take up of the National Approach. NHMRC continues to work with Private Hospitals, Universities and Medical Research Institutes to promote the mutual acceptance of single ethical review.
In response to Recommendation C, NHMRC developed a draft list of standard items associated with clinical trials. This list was subject to public consultation in 2011. The Australian Government will now work with stakeholders to determine a national efficient cost for each item, in line with actual activity and cost-recovery principles.
In response to Recommendation E, the Australian Government has launched www.australianclinicaltrials.gov.au - a consumer-friendly clinical trials website. This website includes a searchable list of organisations engaged in clinical trials. NHMRC and DIISTRE also conducted a feasibility study for the development of a searchable portal for clinical trials (Recommendation F).
In response to Recommendation H, the Department of Innovation, Industry, Science and Research liaised broadly with stakeholders and contracted the Consumers Health Forum of Australia (CHF) to undertake extensive research and consultation to develop this consumer factsheet on clinical trials titled "Consumer Guide to Clinical Trials" to raise the general community and consumers awareness of clinical trials. This Factsheet is now available on the www.australianclinicaltrials.gov.au .
In July 2011 the NHMRC sought comment on a list of clinical trial networks. The development of this list was a requirement of Recommendation I of the CTAG report. The list of networks now forms part of www.australianclinicaltrials.gov.au but can be found here: Clinical Trial Networks List (PDF, 55KB).
Information will be displayed as set out below with a sub category or title where appropriate. NHMRC will maintain this list on an ongoing basis.
|Networks Name||Internet Address|
|National Health and Medical Research Council (NHMRC)||http://www.nhmrc.gov.au|
If your site information changes, further additions or any questions please contact us by emailing HREP@nhmrc.gov.au.
Some recommendations in the CTAG report are beyond NHMRC’s direct influence. Nevertheless, NHMRC, the Australian Department of Health and Ageing and the Department of Industry, Innovation, Science, Research and Tertiary Education are working together to bring these issues to the attention of the Australian Health Ministers’ Advisory Council to facilitate participation by States and Territories.