Clinical Trials Advisory Committee Meeting Communique 28 August 2015

Clinical Trials Advisory Committee Meeting Communiqué
28 August 2015

The Clinical Trials Advisory Committee (CTAC) provides advice from senior stakeholder representatives to the Australian Government on its work program to progress clinical trials reform. CTAC met for the fifth time on Friday, 28 August 2015.

In this meeting, CTAC members:

  • Endorsed the Clinical Trials Framework for Action developed by the Department of Health, in consultation with the Department of Industry and Science and the NHMRC, noting that the framework is a living document that will change over time with future opportunities for refinement.
  • Agreed that the framework is a useful document to guide the work of the CTAC and Clinical Trials Jurisdictional Working Group (CTJWG) including their communications activities, and for the framework to be made publicly available.
  • Noted progress of each initiative being undertaken by the Department of Industry and Science, the Department of Health and the NHMRC to improve the clinical trials environment in Australia.
  • Acknowledged progress of the Communications Working Group and look forward to considering detailed strategies and work plans at the next CTAC meeting.
  • Noted that the CTJWG Implementation Plan and framework for National Aggregate Statistics for clinical trials have now been endorsed by the Council of Australian Governments Health Committee.
  • Noted that Health Outcomes International (HOI) had completed an in-depth analysis of recently conducted clinical trials in Australia to determine the critical success factors and/or reasons for failure. Members agreed that the  HOI report will be discussed in detail at the next CTAC meeting.
  • Noted that the Independent Hospital Pricing Authority’s (IHPA) Determination of Standard Costs associated with conducting clinical trials in Australia 2015 is expected to be released by the end of September 2015 together with the HealthConsult report Development of a table of standard costs for conducting clinical trials in Australia on the IHPA website.
  • Noted that the Department of Health is developing a discussion paper covering the complexities and limitations of the list, in conjunction with the IHPA, which will also be published with the IHPA and HealthConsult reports.

The Therapeutic Goods Administration advised that it is aware of concerns regarding the new Clinical Trial Notification (CTN) form and that it is currently working to resolve them.

Austrade provided a presentation to members1 on its role and activities promoting exports from the health and medical sector, including their recently released Clinical Trials Capability Report. Members discussed promotion of the report.

An overview of the activities being undertaken by the Australian Government is available here with detailed information on the progress of each initiative to improve the clinical trials environment in Australia available on the respective government webpages.

The next CTAC meeting is expected to be held on 3 December 2015.

1 If you have trouble accessing the information within the presentation you will need to contact the document author directly ctacsecretariat@industry.gov.au

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