Clinical trials benefit patients, advance medical knowledge and are estimated to be worth around $1 billion to the Australian economy each year. The environment in which clinical trials are conducted is complex, often occurring across multiple jurisdictions and with every study needing ethics and governance approvals before it can commence.
The Australian Government is leading a body of work to improve the Australian clinical trials environment with a view to improving health outcomes and increasing international investment in Australia.
The Department of Health is working through a range of government departments, committees, and industry stakeholders to progress improvements to the clinical trial environment. Much of this work is being achieved through collaboration between Commonwealth and jurisdictional agencies, including the Clinical Trials Jurisdictional Working Group (see below) and the National Health and Medical Research Council (NHMRC).
Improvement of the clinical trials environment is occurring through strategies to:
- enhance participation in clinical trials;
- continue to build a best practice, quality driven clinical trials sector;
- facilitate a predictable operating environment for clinical trials; and
- ensure that Australia’s clinical trials capability and capacity is internationally acknowledged.
Clinical Trials Jurisdictional Working Group (CTJWG)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, state and territory health departments, and the National Health and Medical Research Council (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; and
- oversighted a study to investigate the issues, underlying barriers and enablers to recruitment and retention of patients to clinical trials, with a view to implementing effective change (see below).
In April 2016 the Council of Australian Governments (COAG) Health Council noted that while jurisdictions have worked to improve the environment for clinical trials, issues of fragmentation and inefficiencies remain, that impact on Australia’s attractiveness as a preferred location for trials. Health Ministers agreed to develop approaches to organise sites to better support and streamline clinical trials processes in Australia.
In response to the April 2016 decision of the COAG Health Council noted above, the CTJWG developed a set of Principles and Priority Action Areas to underpin regional redesign of jurisdictional clinical trial systems, which have been endorsed by the Hospitals Principal Committee, Australian Health Ministers Advisory Council (AHMAC) and the COAG Health Council.
Another important recent development is the Australian Government’s Encouraging More Clinical Trials in Australia budget measure, under which $7 million will be available nationally to assist State and Territory governments achieve system redesign in accordance with the COAG Health Council agenda. Among other things, this agenda seeks to establish central points of contact to improve system navigation for sponsors and participants, streamline trial processes and time to trial start-up, and improve workforce capacity.
National Aggregate Statistics (NAS)The interim Second Activity Report on Clinical Trials in Australian Public Health Institutions 2015-16 (Second Activity Report), developed under the Framework for National Aggregate Statistics (NAS Framework), was endorsed by Australian Health Ministers in June 2017.
The data captures the majority of new clinical trials approved in public health organisations in five jurisdictions in Australia. It includes the time taken for each of the two approvals needed for every clinical trial in Australia - ethics and research governance. The findings should be viewed as provisional, and part of continuous improvements efforts to strengthen capability. While the data captures the majority of new clinical trials approved, there are a number of missing data items. State and territory governments are actively addressing these deficiencies, however it is not yet possible to estimate the impact on findings.
Key findings suggest that in public health organisations in Australia in 2015-16:
- over 700 new clinical trials were approved across five jurisdictions;
- new clinical trials were predominantly commercially sponsored;
- the majority of new clinical trials were Phase 2 or Phase 3; and
- start-up time for clinical trials was still longer than desired.
- Second Activity Report on Clinical Trials in Australian Public Health Institutions 2015–16 (Word 691 KB)
- Second Activity Report on Clinical Trials in Australian Public Health Institutions 2015–16 (PDF 514 KB)
Report ‘Scoping and analysis of recruitment and retention in Australian clinical trials’The Department of Health contracted Ernst and Young (EY) on behalf of the Clinical Trials Jurisdictional Working Group (CTJWG) to analyse issues around recruitment and retention in Australian clinical trials. These are complex issues because no single government or entity controls all the levers to effect positive change. EY was asked to provide advice on the best ways to enhance clinical trials recruitment in Australia, and undertook broad consultations as part of its research.
The EY Report includes a range of recommendations to boost clinical trials recruitment and retention in Australia. Some of the key recommendations call for collaborative government leadership, and establishment of dedicated structures to improve clinical trials coordination and administration across Australia. The CTJWG will now look at the best ways to progress the recommendations in partnership with other agencies and stakeholders.
This activity is a key element of the Australian Government’s efforts to enhance the Australian clinical trials environment with a view to improving health outcomes and increasing international investment in Australia. It is part of a program of work being conducted by the Department in conjunction with a broad range of stakeholders, and in the context of increasing government investment in health and medical research.
- Scoping and analysis of recruitment and retention in Australian clinical trials - Final report June 2016 (Word 130 KB)
- Scoping and analysis of recruitment and retention in Australian clinical trials - Final report June 2016 (PDF 620 KB)
Industry LiaisonIn 2015 the CTJWG consulted with industry stakeholders through liaison meetings held in Sydney and Melbourne to share and test CTJWG’s identified priorities and work program. The purpose was to harness the experience and perspectives of contract research organisations (CROs) and front-line industry representatives and gain a better understanding of their current priorities for the clinical trials sector.
- Clinical Trials Jurisdictional Working Group - Sydney and Melbourne Industry Liaison Meetings (Word 42 KB)
- Clinical Trials Jurisdictional Working Group - Sydney and Melbourne Industry Liaison Meetings (PDF 735 KB)
Critical Success FactorsThe Department of Health contracted 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 project commenced in February 2015 and was completed in June 2015.
- Analysis of recently conducted clinical trials – a study conducted by Health Outcomes International (HOI) (Word 678 KB)
- Analysis of recently conducted clinical trials – a study conducted by Health Outcomes International (HOI) (PDF 961 KB)
Independent Hospital Pricing Authority’s (IHPA) determinationIn 2013 the Department of Health funded the development of a table of standardised costs for conducting clinical trials in Australia. This work was first completed in 2013 by the NHMRC and the IHPA, but was subsequently revised based on stakeholder feedback.
The NHMRC prepared a revised list of clinical trial items and the IHPA released its Determination on 30 September 2015. The primary objective in developing the determination was to improve transparency of clinical trial costs and enhance efficiency of contract negotiations. Use of the Determination is not mandatory. Rather, the Determination is intended to serve as a reference point to negotiate price, and sites and sponsors can adapt the Determination based on trial-specific circumstances.
A link to the final Determination is below: