CTAG Coordination Group Meeting 2

Meeting 2

Monday 25 July 2011, 10:00am to 12:00pm
Venue: Department of Innovation, Industry, Science and Research (Canberra)

The Clinical Trials Action Group (CTAG) Coordination Group (the Group) met to discuss progress on implementation of the CTAG recommendations. This paper provides a summary of the outcomes of the meeting.

Recommendation A: The National Health and Medical Research Council (NHMRC) reported that the Harmonisation of Multi-centre Ethical Review (HoMER) Reference Group had considered the ‘Research Governance Handbook: For use as part of the national approach to single ethical review’, at its last meeting and will finalise the handbook out-of-session in early August. Guidance on monitoring is currently being developed and a discussion paper is out for targeted consultation. It was noted that the next meeting of Australian Health Ministers Advisory Council (AHMAC) is scheduled for late September, and that CTAG and the HoMER projects are scheduled for discussion at this meeting. Dr Suzanne Hasthorpe of the Victorian Department of Health agreed to prepare a discussion paper for the Group in consultation with jurisdictions by mid August on Recommendation A  'clinical trials approvals performance measures' . This will assist in considering issues prior to the AHMAC meeting.

Recommendation B: Professor Warwick Anderson, CEO of the NHMRC, has written to Deputy Vice-Chancellors of Research (DVCR) to inform them of the benefits of adopting the national approach to single ethical review as well highlighting the reforms as outlined in Recommendation A of the CTAG report and to invite their cooperation. It was agreed at the meeting that a DVCR representative be invited to the 3rd CTAG Coordination Group meeting as well as a representative from Australian Private Hospitals Association. NHMRC also agreed to provide information on the institutions with HoMER certified ethical review processes. This information has subsequently been provided, as follows:

During 2010, 33 institutions were certified through the National Certification Scheme. This includes 22 public health, 7 private institutions and 4 universities, with Institutions also certified for review specialities including Clinical Trials, Population and/or public health and Qualitative health research, among others. A full list of certified institutions and the list of categories that they have been certified in are available at the NHMRC website.

Recommendation C: The NHMRC have made available a Table of Standards Items on their web page which is open for comment until 12 August 2011. The Independent Hospital Pricing Authority has not yet been established, this is expected to take some time. Once established, it will require considerable input from jurisdictions to develop detailed costings on individual items. Dr Lloyd of Southern Star Research noted that there was currently an issue with the Start Up costs of studies in Australia. These costs should be examined in the near future rather than waiting for the review to be conducted by the Independent Hospital Pricing Authority. Dr Lloyd indicated he would seek preliminary metrics/advice from the Research and Development Taskforce of the Pharmaceuticals Industry Council.

Recommendation D: The group noted that the Personally Controlled E-Health Record (PCEHR) timetable plans implementation of the initial PCEHR system by July 2012. An associated effort to develop supporting legislation is also underway. Dr Bond noted that this version of PCEHR doesn’t explicitly incorporate Clinical Trials as a consumer of PCEHR content but existing considerations don’t preclude such relationships. The Department of Health and Ageing, with assistance from NEHTA, is establishing an investigative group to identify the functional services of the PCEHR which can further support clinical trials and other secondary uses. In support of recommendation D, this group will identify the value of proposed data collections, privacy and consent options, and secondary use applications of infrastructure functions including authentication, repositories, registries, etc. ensuring clinical trial needs are addressed in future expansion of e-health and PCEHR. This group is expected to provide its advice in September.

Recommendations E & F: The NHMRC and DIISR outlined progress with the portal investigations. The Study Steering Group met on 22 July 2011 in Brisbane to discuss the draft report. Discussions centred around the point at which to collect the trial information; standards for the lay summary; e-health enabling infrastructure (health provider authentication etc.); and the diverse needs of key user groups that the portal would be designed to meet. A second draft report is expected mid August. Appropriate consultation will be needed with key groups to ensure their needs are being addressed. The steering group would determine the process for consultation and finalising the report after considering the next draft.

Recommendation G: This will be incorporated into the scope of Recommendations D and E/F.

Recommendation H: The Consumers Health Forum (CHF) has finalised and tested its Clinical Trials Factsheet, which is now being prepared for printing. It will be available electronically on the CHF website. DIISR also supported Clinical Trials Connect to conduct information nights on web-based trial recruitment. DIISR is in the process of drafting a communications strategy for clinical trials.

Recommendation I: The NHMRC has developed a list of clinical trial networks which it is seeking comment on until 29 July 2011. It was suggested a link to the NHMRC list of trial networks could be incorporated into the CHF Clinical Trials Factsheet. It was also suggested that DIISR give an overview of the Strategic Research Infrastructure Roadmap at the next meeting to look at how patient networks could benefit from the Roadmap initiatives.

Recommendation J: DIISR presented a paper for comment on an approach for collecting a range of metrics to show value and performance of clinical trials. Comments or input to the paper are invited, and can be forwarded to Ian Tranter, Manager of the Innovation Research Section, DIISR.

It was agreed that the next meeting will be held 1 September 2011.

Attendees

Name

Position/Agency

Peter Chesworth (Chair)

General Manager, Pharmaceuticals, Health Industries & Enabling Technologies Branch, Department of Innovation, Industry, Science and Research (DIISR)

Gordon McGurk

A/g Executive Director, Research Quality Branch , NHMRC

Margaret Corcoran

A/g Manager, Pharmaceuticals Industry Strategy & Environment Section, DIISR

Dr Suzanne Hasthorpe

Department of Health, Victoria (representing Qld, NSW & Vic)

Dr Anthony Gill

Director, Experimental Products Section, Office of Scientific Evaluation, Therapeutic Goods Administration

John Brewer

E-Health Branch, Department of Health and Ageing (DoHA)

Sharon Wadey

Assistant Director (Acting), Quality Use of Medicines and Industry Information Section, DoHA

Jillian Barr

Assistant Director, Research Integrity, NHMRC

Deborah Monk

Medicines Australia (MA)

Alex Gosman

Pharmaceuticals Industry Council (PIC)

Mike Stelzig

A/g Asst Manager, Pharmaceuticals Industry Strategy & Environment Section, DIISR

Dr David Lloyd

Managing Director, Southern Star Research & Member of the Research & Development Task Force (RDTF)

Dr Andy Bond

National E-Health Transition Authority

George Chen

Innovation Research, DIISR


Apologies

 

Carol Bennett

CEO, Consumers Health Forum

Andrew Stanley

Policy and Intergovernment Relations Division, SA Health (Representing WA, SA and TAS)

Mr Nick Henderson

Assistant Secretary, Policy and Analysis Branch, Department of Health and Ageing (DoHA)

Paul Creech

Director, Quality Use of Medicines Section, Pharmaceutical Benefits Division, DoHA

Dr Clive Morris

Head, Research Group, NHMRC

Sarah Lawson

Policy and Intergovernment Relations Division, SA Health

Mitch Kirkman

Novartis Pharmaceuticals & Member of RDTF & CTAG

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