Clinical Trials - Phase 2 Advisory Committee
Communique - Meeting 1, 26 November 2019
This Communique provides an update from The Australian Commission on Safety and Quality in Health Care (the Commission) on Clinical Trials – Phase 2 Advisory Committee (Advisory Committee) meetings.
We gratefully acknowledge the critical role of the Commission in leading this work.
The main objectives of this project include: the pilot implementation of the National Clinical Trials Governance Framework (Governance Framework); the development of supporting resources for the pilot including the Governance Framework self-assessment tool and operational metrics tool, the development of strategies to meet the National Safety and Quality Health Service (NSQHS) Standards 3 to 8 for clinical trial services, and finalisation of the draft national Site Specific Assessment (SSA) tool in national pilot in mid-2020.
Background
In 2016, the Council of Australian Governments Health Council noted that, while jurisdictions have worked to improve the environment for clinical trials, issues of fragmentation and inefficiency remain that impact on Australia's attractiveness as a preferred location for clinical trials. The Australian Health Ministers' Advisory Council was tasked to work up options for the development of models of best practice to organise sites and to improve administered efficiencies, better engage sponsors and improve trial start up times.
The Australian Commission on Safety and Quality in Health Care (the Commission), under contract with the Australian Government Department of Health, has developed the Governance Framework as the first step towards the accreditation of health services for clinical trial service provision. The Commission is now undertaking phase 2 of the Governance Framework project. The Advisory Committee has been established to provide expert advice on the development of the deliverables associated with the project.
Clinical Trials - Phase 2 Advisory Committee: Meeting 1
The first meeting of the Advisory Committee was held on 26 November 2019 at the Commission offices in Sydney.
At the meeting members:
- Received the background to the project.
- Considered the proposed approach to the pilot implementation of the Governance Framework.
- Received an overview of the resources developed to support the pilot implementation of the Governance Framework.
- Considered the proposed approach to the pilot of the national SSA as a digital tool.
Next Steps
In the coming months, the Commission project team will:
- Finalise the resources to support the pilot implementation of the Governance Framework.
- Circulate the Expression of Interest to health service organisations inviting their participation in the pilot implementation of the Governance Framework, and select the 12 national pilot sites.
Updates on this work will be provided to the Advisory Committee Members at the next Advisory Committee meeting in March 2020.
Enquiries
Further information about the Clinical Trials - Phase 2 project will be published on the Commission website in early 2020.
If you would like to be added to the Clinical Trials - Phase 2 project distribution list and receive further correspondence about the progress of this project, please email your details to CTGovernance@safetyandquality.gov.au.