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, 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:
http://minister.innovation.gov.au/Carr/MediaReleases/Pages/REPORTBOOSTSCLINICALTRIALSEFFORTS.aspx
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:
http://www.innovation.gov.au/Industry/PharmaceuticalsandHealthTechnologies/ClinicalTrialsActionGroup/Pages/default.aspx
Progressing the CTAG recommendations
A number of recommendations in the CTAG report involve the NHMRC. Recommendation A of the CTAG Report relates directly to the NHMRC’s Harmonisation of Multi-centre Ethical Review (HoMER) initiative, under the auspices of the Australian Health Ministers’ Advisory Council (AHMAC).
NHMRC has developed the following tools to support the acceptance of a single ethical review:
- a national certification scheme for certifying institutional processes for ethical review (37 institutions have been certified);
- standardised patient information and consent forms;
- template HREC letters;
- information on roles and responsibilities in single ethical review;
- best practice guidance on information sharing activities for single ethical review of multi-center research;
- Research Governance Handbook: Guidance for the national approach to single ethical review;
- information on insurance and indemnity; and
- Human Research Ethics Portal http://hrep.nhmrc.gov.au.
The following projects will be completed before the end of 2011:
- a compilation of legislation that applies to the ethical review of human research at a Commonwealth, State and Territory level; and
- guidance on monitoring arrangements.
View further information about the national approach to single ethical review.
View further information about clinical trials.
In response to Recommendation C, NHMRC developed a draft list of standard items for public consultation. Consultation has closed and ONHMRC staff are working on revising the list on the basis of the comments received.
In response to Recommendation E, NHMRC is working with the Australia New Zealand Clinical Trials Registry, and with the Department of Innovation, Industry, Science and Research to conduct 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 liased 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.
In July 2011 the National Health Medical Research Council (NHMRC) sought comment on a list of clinical trial networks. The development of this list was a requirement of Recommendation I of the Clinical Trials Action Group (CTAG) report.
NHMRC undertook the identification of known clinical trials networks and related contacts to provide support and to improve collaboration in response to this Recommendation and a Clinical Trial Networks List (PDF, 55KB) was created.
If you’re clinical trial network would like to be identified and the networks name and website address appear on the list of Clinical Trial Networks on the NHMRC Clinical Trials Action Group (CTAG) webpage please notify us by emailing HREP@nhmrc.gov.au.
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 and the Australian Government Department of Health and Ageing are working together to bring these issues to the attention of the Australian Health Ministers’ Advisory Council to facilitate participation by States and Territories.
An overview of the recommendations shows progress being made towards implementing the recommendations with which NHMRC is involved. View the overview of recommendations (PDF, 282KB) for further information. This overview will be kept under review and updated as progress is made.
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