Clinical trials contribute over $1.1bn annually to the Australian research and development economy. More importantly, they give Australian patients access to potentially life-saving treatments. However, ongoing issues of fragmentation and inefficiency impact on Australia’s attractiveness as a preferred location for clinical trials.
As a first step toward a nationally consistent accreditation approach for health services undertaking clinical trials, the Australian Commission on Safety and Quality in Health Care (ACSQHC or the Commission) has been contracted by the Australian Government Department of Health on behalf of all jurisdictions to develop the national Clinical Trials Governance Framework (the Governance Framework).
The Governance Framework will be consistent with existing national standards and regulations for the conduct of clinical trials in Australia. It will also align with the Commission’s National Safety and Quality Health Service Standards (second edition) and the National Model Clinical Governance Framework.
The Governance Framework and accreditation standard represents a priority area agreed by governments, to strengthen and enhance consistency of governance arrangements for trials, and provide clarity to governments, health services, hospital administrators, clinicians and others responsible for delivering clinical trials. It is due for completion in mid-2019.
In April 2016, The Council of Australian Governments Health Council (CHC) noted that issues remain that impact on Australia’s attractiveness as a preferred location for trials. The Australian Health Ministers’ Advisory Council (AHMAC) was tasked to work up options for the development of models of best practice to improve administered efficiencies, better engage sponsors and improve trial start up times.
The full AHMAC response, developed on its behalf by the Clinical Trials Jurisdictional Working Group (CTJWG), which included a recommendation for a national Governance Framework, was endorsed by the CHC in 2017. The CTJWG has since been reconvened as the Clinical Trials Project Reference Group (CTPRG). The CTPRG is an expert advisory sub-group within the Clinical Principals Committee under AHMAC.
Progress to date
The Commission has undertaken a review of the national and international literature on approaches to clinical trials governance and is currently mapping jurisdictional clinical trial policies and processes. A project Steering Committee has been established, and the Commission is engaging with jurisdictions through its Inter-Jurisdictional Committee and the CTPRG.
A series of stakeholder consultation workshops will commence in late 2018. This consultation will be open to key organisations and individuals with an interest or working in the clinical trials sector. Information about the project is available on the Commission’s website.
Enquiries on the project may be sent to CTgovernance@safetyandquality.gov.au