Clinical trials bring in more than $1.1 billion per year to the Australian R&D economy. More importantly, they provide access to life-saving therapies for Australian patients. That said, persisting problems of fragmentation and inefficiency affect the attractiveness of Australia as a location of choice for clinical trials. The Australian Commission on Safety and Quality in Health Care (ACSQHC or the Commission) is working with the Australian Government Department of Health on behalf of all jurisdictions to create the National Clinical Trials Governance (the Governance Framework) as a first step towards a nationally uniform accreditation approach for health services conducting clinical trials.
The governance framework for conducting clinical trials in Australia will be in line with the existing national standards and regulations. In addition, it will be consistent with the second edition of the National Safety and Quality Health Service Standards as well as the National Model Clinical Governance Framework. The Governance Framework and Accreditation Standard is a high priority area agreed upon by governments to solidify and help improve the consistency of clinical trial governance arrangements and offer clarity to governments, health services, hospital management, physicians, and other authorities involved in the process. It is expected to be completed in mid-2019.
Background of the Clinical Trial Governance Framework
The Council of Australian Governments Health Council (CHC) indicated in April 2016 that problems remain affecting the attractiveness of Australia as a preferred destination for clinical trials. The Advisory Council of Australian Health Ministers (AHMAC) was put in charge of developing options for best practice models to enhance administered efficiencies, better involve sponsors and reduce start-up times for clinical trials. In 2017, the CHC endorsed the full AHMAC response developed by the Clinical Trials Jurisdictional Working Group (CTJWG) on its behalf, which included a recommendation for a national governance framework. Since then the CTJWG has been reappointed as the Clinical Trials Project Reference Group (CTPRG). It is an expert advisory sub-group within the Clinical Principals Committee under AHMAC.
Progress to date
The Commission has initiated an evaluation of regional and global literature on governance methods to clinical trials and is presently mapping the policies and processes of jurisdictional clinical trials. A project steering committee has been set up and, through its Inter-Jurisdictional Committee and the CTPRG, the Commission is actively engaging with jurisdictions.
Next Steps
A number of consultation workshops with stakeholders began at the end of 2018. This consultation has been open to leading organizations and individuals in the clinical trials industry who are already involved with or have an interest in clinical trials. More information on the project can be found on the website of the Commission.
Contact
Enquiries on the project are to be sent to CTgovernance@safetyandquality.gov.au
At Armstrong Clinical we offer a number of consulting services that can help you navigate the regulatory framework and get your clinical trials going in the shortest possible timeframe. For more information on how our services can benefit your organization, please feel free to get in touch with us.