National Clinical Trials Governance Framework Pilot: Update

Topics:Advocacy

Clinical Trials - Phase 2 Advisory Committee
Communique - Meeting 5, 30 June 2021

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.

Background

In November 2019, the National Clinical Trials Governance Framework (Governance Framework) was endorsed by all Health Ministers. The Governance Framework provides the first step toward the accreditation of health services for the conduct of clinical trials. The Commission conducted a national pilot of the Governance Framework between September 2020 and March 2021.

Clinical Trials - Phase 2 Advisory Committee: Meeting 5

The fifth meeting of the Advisory Committee was held on 30 June 2021 via videoconference. At the meeting, members received an update on the finalisation of Governance Framework pilot report and status of Clinical Trial – Phase 2 project deliverables. It was agreed that the Advisory Committee’s Terms of Reference would be extended for members to meet and discuss the pilot report and implications of the pilot outcomes.


An overview of the national One-Stop-Shop and National Clinical Trials Front Door was provided to members: At its core, the national One-Stop-Shop should provide:

  • All components of a national cross-government research workflow and associated management system and approvals platform housed within a central platform (including ethics, local SSA and authorisation with full research management functionality for any user ie: public health system or private, not-for-profit and industry).
  • Embedded next generation World Health Organisation (WHO) Australian primary national clinical trials registry with automated registration to facilitate best-practice access to trials for patients and strategic capability for governments and stakeholders. This, together with a capability to fulfil requirements of the Australian and New Zealand Primary World Health Organisation Registry Network associated with the International Clinical Trials Registry Platform (ICTRP).
  • Incorporate national clinical trials systems such as the clinical trial notification (CTN) and clinical trials approvals (CTA) schemes as well as aspects of GCP Site Inspection Program managed by the TGA, together with the capacity to incorporate other relevant approvals systems (such as those required by the Gene Technology Regulator etc).
  • Sophisticated reporting functionalities for different users – from key performance indicators that can continue to benchmark and drive improvements across the sector, to site-level reporting and dashboards for trial coordinators, sites and sponsors.

Members, their organisations and stakeholders are encouraged to register with the Commission to participate in these consultations.

Next Steps

In the coming weeks, the Commission project team will:

  • Extend the Terms of Reference of the Advisory Committee
  • Finalise the pilot report and provide it to the Advisory Committee Members for review and feedback
  • Progress the pilot outcomes and recommendations through the Commission’s governance process and the Health Council for endorsement by all Australian Health Ministers.

The Commission will be recommending implementation from 2022 with health services being assessed against the maturity scale for the first three years.

Enquiries

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 [email protected].

Find out more

Visit the Commission website for more information about the Commission, their current work and opportunities to be involved.

Related News