Clinical Trials – Phase 2 Advisory Committee Communique
Announcement: National Clinical Trials Governance Pilot and COVID-19 Pandemic
This Communique provides an update on the National Clinical trials Governance Framework pilot. This Communique was provided to participants to update their nominating organisations and other key agencies about the project.
The Australian Commission on Safety and Quality in Health Care (the Commission) has finalised the draft National Clinical Trials Governance Framework (Governance Framework). The Governance Framework provides the first step toward the accreditation of health services for the conduct of clinical trials. In November 2019, the COAG Health Council endorsed the Governance Framework and supporting documents including, the Literature Review and Mapping Exercise Report and agreed for the Commission to pilot the Governance Framework in health service organisations from January 2020.
National Clinical Trials Governance Pilot and COVID-19 Pandemic
The pilot of the Governance Framework was announced on 25 February 2020, and the draft Governance Framework; the Literature Review; the Mapping Exercise Report; fact sheets and video tutorial were made publicly available on the Commission’s website.
The Expression of Interest for health services to participate in the pilot closed on Friday 20 March 2020. The Commission had over 40 health services respond to participate in level 2 (level 2 sites will receive mentoring and support to undertake the gap analysis and the onsite assessment), and 50 health services requested to participate in level 1.
Given the increased burden that COVID-19 presents across the health sector including clinical trials, the Commission together with the Chair, Professor Chris Brook and the Australian Government Department of Health have agreed to extend the timeline for the pilot of the Governance Framework. The timeframe for undertaking the pilot will be extended through to the end of the year to ensure the pilot is undertaken at the most appropriate time for health services. The web-based tools and resources will be released in the coming months.
Further information about the pilot of the Governance Framework can be found on the Commission's website or by contacting the Commission's Clinical Trials team at CTGovernance@safetyandquality.gov.au.