Australian Government Clinical Trials Initiatives

The Australian Government is undertaking initiatives to improve the clinical trials environment in Australia and through which increase Australia’s international competitiveness in clinical trials.

An overview of the activities currently being undertaken is outlined below.

Progress to improve clinical trials in Australia

Further information, including completed activities, is available on the respective government webpages:

Current Activities

DATE OF LAST UPDATE:  1 June 2017
Working with states, territories and other key stakeholders on a nationally consistent approach to clinical trials
Summary Activity Progress
Streamlining Research Governance

 

NHMRC has developed a ‘Good Practice Process’ for the site assessment and site authorisation phases of clinical trials research governance. 

Following piloting of the Process at 16 sites throughout Australia, on average, more than 100 days was able to be removed from the time taken for clinical trial commencement.

The Good Practice Process and the report from the Pilots is now available on the Australian Clinical Trials website. NHMRC is working with 9 sites on Phase 2 of the Good Practice Process. A webinar on the Process was held in conjunction with ARCS on 14 February 2017. The Phase 2 draft final reports have been submitted and are currently being reviewed.

Clinical Trials Jurisdictional Working Group

The Clinical Trials Jurisdictional Working Group (CTJWG) was established in July 2014 to identify and address barriers to, and enablers for, multi-jurisdictional clinical trials and improve international competitiveness for clinical trials.  It involves senior officials from Commonwealth and state and territory health departments, and the NHMRC. The CTJWG works in collaboration with a range of key stakeholders, including Industry, to progress its program of work.

Since its inception the CTJWG has:

  • developed a program of work to address identified barriers in the current environment;
  • consulted widely and developed a Clinical Trials Framework for Action (the Framework) to enhance collaboration and coordination of work underway to improve the clinical trials environment in Australia;
  • agreed a framework for collection of national aggregate statistics on clinical trials that will be progressively implemented by all jurisdictions and facilitate a quality improvement approach to the sector;
  • continued to work with the Department of Industry, Innovation and Science, the clinical trials sector and the NHMRC to develop a comprehensive, national communications strategy to convey important messages about clinical trials;
  • commenced work to investigate the issues, underlying barriers and enablers to recruitment to clinical trials, with a view to implementing effective change; and 
  • engaged Health Outcomes International (HOI) to conduct an analysis of recently conducted clinical trials in Australia to determine the critical success factors and/or reasons for failure of clinical trials  in Australia.  The focus of the research was on pharmaceutical and medical device trials conducted within the last five years that were commercially funded and conducted across more than one jurisdiction.  The report from this project can be found on the Department of Health’s website.
  • engaged (through the Department of Health) EY to undertake an analysis of issues in relation to recruitment and retention in Australian clinical trials.  The report from this project can be found on the Department of Health’s website.
  • Other activities for the CTJWG are outlined below.
  • In response to a directive from the COAG Health Council, Members are developing plans to reform the clinical trials sector in Australia through regional redesign with a focus on central points of contact and streamlining clinical trial processes.
  • Members developed Principles and Priority Action Areas to underpin the reforms. This document has been endorsed by the Hospitals Principal Committee, AHMAC and COAG Health Council.
  • In December 2016, the Commonwealth Government announced the initiative Encouraging More Clinical Trials in Australia, which will provide up to $7 million nationally to assist jurisdictions in achieving the clinical trials reforms. Funding for this initiative will commence from July 2017.
Standard table of costs for clinical trial items Determination of standard costs associated with conducting clinical trials in Australia 2015. The Independent Hospital Pricing Authority (IHPA) released its Determination of standard costs associated with conducting clinical trials in Australia 2015 on 30 September 2015. Both the Determination and the Final Report can be found on the IHPA Website.
Human Research Ethics Application - Update 

 

NHMRC in conjunction with a Human Research Ethics Application (HREA) Advisory Group has developed a common human research ethics application (HREA). The HREA is a streamlined and contemporary ethics application that uses dynamic content and guidance to assist researchers to consider and address the principles of the National Statement on Ethical Conduct in Human Research, 2007.

HREA was released on 14 December 2016.There are currently 4713 registered users. Further information can be found on the Australian Clinical Trials website.

Safety Monitoring and reporting 

NHMRC has published updated guidance on Safety Monitoring and Reporting in Clinical Trials  on the Australian Clinical Trials website. This has been endorsed by the Therapeutic Goods Administration.

Supplementary guidance on Risk-adapted Clinical Trials, use of Data Safety Monitoring Boards/Committees and handling Serious Protocol Breaches was released for a targeted consultation in March 2017.

NHMRC is now finalising the supplementary guidance. Subject to endorsement by the Therapeutic Goods Administration and the Australian Health Ethics Committee, the supplementary guidance will be published in August 2017.

Streamlining Ethics Review - Update 
  1. NHMRC has established 2 independent, national scientific committees to provide advice to researchers and HRECs on medical device trials and complex genetic research and has engaged Bellberry Limited to provide secretariat services to the scientific committees.
  2. NHMRC has conducted a review of the National Certification Scheme for institutional ethical review processes of multi-centre human research (the National Certification Scheme).
  3. Through engagement of a consultant, NHMRC will develop a tool for HRECs to identify relevant laws that relate to consent a guardianship requirements.
  1. These committees were launched in January 2017.Further information can be found on the Australian Clinical Trials website. 
  2. NHMRC is reviewing the findings from the review and preparing a response. The report and response will be published on the NHMRC website by June 2017.
  3. NHMRC has now finalised a draft report on relevant State, Territory and National laws and a series of Fact Sheets on jurisdictional consent and guardianship laws. These are now published on the NHMRC website. 
Training and education for clinical researchers and support staff in industry and academia
Summary Activity Progress
Development and delivery of VET Accredited Course The Department of Industry, Innovation and Science commissioned Swinburne University to develop a VET accredited course to be delivered to hospital staff who oversee clinical trials, and researchers who submit clinical trials applications to assist in improving the timeliness of clinical trial applications. 10562NAT Course In Clinical Trial Application, Preparation, Submission and Review, received ASQA accreditation on 8 April 2015, and is accredited until 7 April 2020. The course was successfully piloted between  June and September 2015. Information on the course is available on the Department of Education and Training website. Swinburne University of Technology plan to offer the course in future.
Support for clinical trials networks 

NHMRC have conducted a number of activities to support clinical trials networks to improve national co-ordination and communication within and across networks. These include:

 

 
  • Providing support for ACTA to hold an International Symposium of clinical trial networks in October 2015; and

The International Symposium was held in Sydney from 7 – 10 October 2015. Speaker presentations have now been published on the ACTA website.

 
  • Through the work of ACTA, collecting information on the activity of clinical trials networks including the number of clinical trials conducted by networks and recruitment into these trials, and on the contribution networks are making to the health system.
The report from this work has now been published and is available on the NHMRC website.
 
Development of competencies for academic clinical trialists 

NHMRC held a workshop to commence the development of a set of draft competencies and a training framework for academic clinical trialists.

Following agreement from a number of NHMRC’s principal committees, NHMRC will conduct a targeted consultation to determine their acceptability and usability as part of an education framework.

Clinical Trials Portal
Summary Activity Progress
Improve functionality of clinical trials website - Update 

NHMRC is continuing to add stories from participants and researchers on their clinical trial experiences.

 Further 'real stories’ from health care providers have been published as videos on AustralianClinicalTrials.gov.au.

Development of national interactive portal - Update  The Department of Industry, Innovation and Science and NHMRC has worked to expand the functionality of the Australian clinical trials website by developing an interactive portal.

Work on the portal is now completed; and the final set of enhancements ‘went live’ on 20 May 2017, to coincide with International Clinical Trials Day.

Additional functionality now includes:

  • The ability browse clinical trials.
  • new Search for an Australian Clinical Trials Site functionality which enables sponsors to find and contact Australian Clinical Trial Sites (over 150 clinical trial sites are currently listed)
  • a new Clinical Trials Toolkit, containing useful information and resources for conducting a clinical trial in Australia
  • an overview for international sponsors of how to undertake a clinical trial in Australia.
Reporting