CTAG Coordination Group Meeting 3

Meeting 3

Thursday 1 September 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) discussed progress on implementing the recommendations of the CTAG report: Clinically Competitive: Boosting the Business of Clinical Trials in Australia. The meeting is summarised as follows:

Recommendation A:  Members noted concerns raised by State Government representatives regarding the third point of recommendation A, relating to timeframes for ethics and governance review.  The Group agreed that the intention of this point was ambiguous and needs to be clarified prior to Australian Health Ministers Advisory Council (AHMAC) consideration.  Mr Chesworth requested a discussion paper, articulating the areas of uncertainty in recommendation A, to be circulated to the CTAG Coordination Group for consideration of members. 
Some members of the Group expressed the need for other CTAG recommendations (particularly Recommendation D, see below), to be considered at the upcoming AHMAC meeting.  It was noted that the National Health and Medical Research Council (NHMRC) are engaging in discussions with the jurisdictions to identify areas relating to the implementation of Harmonisation of Multi-centre Ethical Review (HoMER) that need to be addressed before full support is provided.

Recommendation B: It was agreed that the resolution of Recommendation A issues on ethics and governance review be resolved before progressing these matters with the Australian Private Hospitals Association and Universities Australia. 

Recommendation C: The NHMRC Table of Standard Items consultation received 30 submissions, which NHMRC are currently working through. NHMRC will work with the Transition Office and Independent Hospital Pricing Authority as it is established, to ensure that the information it provides can be used by the Transition Office for costing purposes.  

Recommendation D: Mr Kirkman (Novartis) noted that the first point of recommendation D

that the Parliamentary Secretaries....propose to AHMAC that it: introduce  policies and /or systems  allowing trial monitors to access trial patients electronic health records (both on-site and remotely) by clinical trial monitors and auditors to the electronic health records of clinical trial participants)

needs to be addressed as a priority in representations to AHMAC.  This issue is becoming increasingly critical as hospitals continue to introduce electronic health records across Australia in sites conducting clinical trials.  There is currently a lack of clear policy for IT hospital managers to understand and facilitate access issues for electronic medical records for trial participants. This issue is quite separate to future PCEHR developments. In particular, the issues around privacy were very different given that ethics committees have approved the trials, and clinical trial participants have given their written consent to their medical records being directly accessed by trial monitors.

Dr Bond advised that the National E-Health and Information Principal Committee of AHMAC would be the relevant body to address this issue.   DoHA was asked to consider how to progress this in the context of the forthcoming AHMAC meeting.  Mr Kirkman was asked to provide a paper to Mr Creech (DoHA) on this matter.

On the second part of the recommendation, that

the clinical research system be a key consideration in the design of e-health standards.. etc

Dr Bond advised that NeHTA is currently establishing a group of relevant experts which will investigate clinical research needs in the context of the PCEHR design and legislation. This group is expected to provide its advice by the end of September 2011.

Recommendations E & F:  The NHMRC and DIISR outlined progress with the portal investigations. The NHMRC held a meeting with the Australia New Zealand Clinical Trials Registry (ANZCTR) to ascertain whether their registry could be updated to provide the functionality as outlined in the CTAG report. The ANZCTR are expected to provide a response to the NHMRC shortly.

A second draft of the portal feasibility study (Recommendation F) was distributed and considered by to the Feasibility Study Steering Group on 29 August 2011.  The recommendations were circulated to the CTAG Coordination Group.  It was agreed at both meetings to limit the metrics collection functionality of the portal to activity metrics initially – with any future functionality of performance metrics to be considered once the portal is up and running.  The Group agreed that it would be appropriate to consult more broadly on the draft of the report as soon as practicable and use the results of this consultation to finalise the report.  MS Watt of CHF noted that there was no consumer representative on the steering group, which DIISR agreed to rectify.

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

Recommendation H:  CHF has finalised and tested its Clinical Trials Factsheet which has been printed and was presented to the Joint Medicines Policy Forum on 31 August 2011 for comment. The fact sheet was well received. The CHF will distribute the fact sheet to their members for comment. 

Recommendation I:  There were no comments regarding this recommendation.

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. Research so far indicates that there is an abundance of data but that it is fragmented and not easily accessible.

Mr Kirkman suggested that an initial pragmatic approach would be to utilise the main existing dataset (eg the CTN data, especially as the proposed move to electronic submission of data by sponsors offers great potential for easy collection of an improved dataset).  CTN data may not capture all types of trials but would capture key trial activity of interest, especially on global trials and would be a dramatic improvement on existing available metrics.  He identified two key priorities for metrics:

  1. Activity (eg by sponsor type, by therapeutic area, by phase, by state) – increasing the reporting capabilities of the TGA Clinical Trial Notification data collection system would provide very good data on Phase I-IV trial activity and, in particular, be very relevant to global trial activity.  Maintaining or increasing trial activity is a key metric in measuring the success or otherwise of the CTAG recommendations and implementation..  Dr Gill advised that the current CTN database and system presently provides limited data for this purpose.  Mr Kirkman proposed that  CTN collection process could be expanded slightly to include extra fields – e.g., on target patient numbers, types of sponsors, actual patient numbers recruited on trial completion, etc.  Mr Kirkman proposed that sponsors would be willing to assist with limited additional data entry on their trials (especially via an electronic CTN submission process) on the basis that much improved trial activity data for Australia would result which would be useful for promoting Australia to global headquarters.  Dr Hasthorpe noted that approximately 13 percent of trials were non-CTN trials, in addition to low risk, follow up and post marketing activity. 
  2. Start up times – the AU RED system currently captures performance information across the three eastern states, which is a record of performance for the majority of trial sites.  This is the current most complete and structured data set that is being maintained in Australia and could provide consistent information on Australia’s performance and trial ‘features’. This could provide valuable information to global decision makers on times to expect for the regulatory process in Australia and to provide evidence that the CTAG process is reducing study start-up times.   Dr Hasthorpe noted that industry would be the most appropriate and reliable source of data on patient numbers recruited and trial stat up time (AuRED records the regulatory process only & proposed number of participants, not the actual recruitment).

The meeting closed at 12.05pm




Peter Chesworth (Chair)

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

Alan Skeates

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

Gordon McGurk

A/g Executive Director, Research Quality Branch , National Health and Medical Research Council (NHMRC)

Jillian Barr

Assistant Director, Research Integrity, NHMRC

Deborah Monk

Medicines Australia (MA)

Alex Gosman

Pharmaceuticals Industry Council (PIC)

Dr David Lloyd

Managing Director, Southern Star Research & Chair, Research & Development Task Force (RDTF)

Dr Andy Bond

National E-Health Transition Authority (NEHTA)

Ian Tranter

Innovation Research, DIISR

Elke Rosche

Innovation Research, DIISR

Sarah Watt

Consumers Health Forum (CHF)

Andrew Stanley

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

Paul Creech

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

Dr Clive Morris

Head, Research Group (NHMRC)

Mitch Kirkman

Novartis Pharmaceuticals & Member of RDTF & CTAG

Margaret Corcoran

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

Mike Stelzig

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

Rachel Ryan

Assistant Manager, Pharmaceuticals Industry Strategy & Environment Section, DIISR



Sarah Lawson

Policy and Intergovernment Relations Division, SA Health

Mr Nick Henderson

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

Sharon Wadey

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


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