Australia is already an attractive location to host clinical trials with an efficient ethics and regulatory framework, diverse participant recruitment pool and high-quality research facilities just a few of the drawcards.
Clinical trials contribute over $1.1bn annually to the Australian economy; so, it is no wonder the council of Australian Governments (COAG) Health Council is revitalizing the clinical trials agenda and looking for further ways of improving the clinical trials process here in Australia. COAG Health Council has since tasked the now Clinical Trials Project Reference Group (CTPRG) to, “develop options for the next steps to stimulate the clinical trials sector to improve administrative efficiencies, better engage sponsors and improve trial start up times and outcomes”. Seven principles have been developed that will underpin these new approaches and include:
- The patient is at the centre of clinical trials
- Research and clinical trials are essential health system activities
- Clinical trials foster a culture of quality, safety and innovation
- Access for patients must be made easier
- Partnerships and collaboration are at the core of any success
- Workforce support is central
- Knowledge and transparency
The CTPRG provided priority action areas that were agreed upon by multiple jurisdictions. Firstly, the development of coordination units, new models designed to centralise and coordinate the management of clinical trials. These units have been designed to play a ‘gateway’ role for sponsors, investigators and participants accessing clinical trials and are designed to reduce the administrative load on trial sites by acting as central points of communication, training and education, as well as facilitating key trial operational functions such as ethics clearance, trial governance and contract management.
The CTPRG also highlighted the need to employ new approaches and build on existing approaches to develop, engage and capitalise on networks and partnerships to drive improvements across the clinical trials sector.
The third priority action area is enhancing data and knowledge systems to allow for fast-tracking agreed metrics collection and facilitation of improved data linking capability. These approaches will ensure quality clinical trial data is gathered to inform system improvement and contribute to better sector knowledge, recruitment and overall performance.
Jurisdictions also agreed to promote research and clinical trials as core business areas by imbedding them into core hospital governance arrangements. The development of KPIs in corporate governance mechanisms and performance agreements sets a strong message that clinical trials are central to quality health care.
Finally, the CTPRG have prioritised introducing clinical trials governance into the well-established Australian Commission on Safety and Quality in Health Care (ACSQHC) standards to create a clinical trials ‘governance framework’ which covers the full spectrum of trials in public hospitals.
On top of the priority action areas, the CTPRG agreed to consider standard care in the context of clinical trials and to inform development of streamlined ethical and governance approval processes for comparative-effectiveness and lower-risk trials. The CTPRG is also considering the feasibility of developing national clinical trials participation levels.
The initiatives put forward by the CTPRG indicates the commitment the Australian Government has in ensuring Australia remains an attractive location to host clinical research.
The Department of Health, 2018, Clinical Trials