Legal Insights

National Clinical Trials Governance Framework pilot: what you need to know

Aaron Kloczko

• 19 November 2020 • 2 min read

The National Clinical Trials Governance Framework pilot commenced on 1 September 2020. Fourteen targeted pilot sites have been selected from across the public and private sectors, Australia-wide. Other health service organisations may participate in the pilot on a voluntary basis.

The National Clinical Trials Governance Framework (Governance Framework) was developed by the Australian Commission on Safety and Quality in Health Care following a comprehensive literature review and mapping exercise of national and jurisdictional legislation, policies and processes applicable to the conduct of clinical trials in Australia.

The Governance Framework is based on the National Safety and Quality Health Service Standards (NSQHS Standards), in particular, Standard 1: Clinical Governance and Standard 2: Partnering with Consumers.

The Governance Framework is part of a broader COAG agenda to encourage and facilitate clinical trials in Australia. The intention is that accreditation to national standards will facilitate clinical trials by optimising key clinical trial governance processes.

The Governance Framework essentially ‘overlays’ and builds upon the existing NSQHS Standards. Conceptually, this approach is explicitly intended to embed clinical trials into routine health service provision. Operationally, the intent is that – for health service organisations undertaking clinical trials – accreditation against the NSQHS Standards will extend to accreditation against the Governance Framework. That is, duplication of accreditation assessment will be avoided.

Importantly – particularly for smaller facilities where clinical trials are typically investigator-led – accreditation against the Governance Framework will be mandatory where the facility is a trial site (i.e. the approving authority under the CTN or CTX scheme).

Subject to the outcome of the pilot, it is anticipated that organisations undertaking clinical trials will be assessed against the Governance Framework over their next accreditation cycle. However, it is contemplated that initial assessment will use a ‘maturity scale’ approach (rather than a binary ‘met/not met’ approach) recognising that organisations will be at different stages of maturity in implementing the Governance Framework across the first cycle.

This article was published in Edition 2 of The Prescription.