(Last Reviewed :  6/07/2010  )

The Minister for Innovation, Industry, Science and Research, Senator the Hon Kim Carr, and the Minister for Health and Ageing, the Hon Nicola Roxon MP, announced the creation of an Action Group for Clinical Trials on 27 October 2009. The Group is co-chaired by the Hon Richard Marles MP, Parliamentary Secretary for Innovation and Industry, and the Hon Mark Butler MP, Parliamentary Secretary for Health. The other members of the Action Group are Professor Jim Bishop AO, Australian Government Chief Medical Officer, Dr Tim Dyke, Executive Director of the HoMER (Harmonisation of Multicentre Ethical Review) at the National Health and Medical Research Council, and Mr Mitch Kirkman of Novartis Pharmaceuticals Australia Pty Ltd and member of the former Pharmaceuticals Industry Strategy Group (PISG). The PISG provided their Final Report (3.61MB) to Minister Carr in January 2009.

The Action Group was charged with developing options to improve the Australian clinical trials operating environment. Their work focuses on five key areas:

  1. developing a clinical trials roadmap;
  2. developing key performance measures for clinical trials;
  3. ensuring the rapid uptake of streamlined ethics, scientific and governance review processes;
  4. strategies to improve patient recruitment; and
  5. developing an ICT strategic plan for clinical trials.

The Action Group, which is a subgroup of the Pharmaceuticals Industry Working Group (PIWG), held its first meeting at Parliament House on 28 October 2009. The Action Group agreed to the formation of five reference groups to progress the five key areas outlined above. Membership of the reference groups comprised key clinical trial stakeholders from Australian, State and Territory Governments, hospitals, clinicians, researchers and industry.

On 30 November 2009, the Action Group invited public submissions to address their key issues.  For a copy of discussion papers please see the links below. Use the following link to view public submissions to the Action Group. Submissions to the Action Group have now closed.

The Action Group submitted their report to Ministers Carr and Roxon on 18 June 2010. Any further action will require authority from Ministers.

 

For enquiries contact:

Manager, Pharmaceuticals Industry Strategy & Environment Section
Pharmaceuticals, Health Industries and Enabling Technologies Branch
Department of Innovation, Industry, Science and Research
GPO Box 9839
Canberra   ACT   2601

Contact: Dr Kirrily Peters 02 6213 6398

Email





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download a PDF or an RTF version of the documents

  1. Developing a Clinical Trials Roadmap  PDF (87 KB)  RTF (1.5 MB)
  2. Developing Key Performance Measures for Clinical Trials  PDF (81 KB)  RTF (1.4 MB)
  3. Ensuring the Rapid Uptake of Streamlined Ethics, Scientific and Governance Review Process PDF (88 KB) 
    RTF (1.5 MB)
  4. Strategies to Improve Patient Recruitment  PDF (85 KB)  RTF (1.8 MB)
  5. Developing an Information and Communications Technology (ICT) Strategic Plan for Clinical Trials  PDF (105 KB)  RTF (1.5 MB)


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