Background

In 2016, all Health Ministers recognised that, while states and territories had worked to improve the environment for clinical trials, issues of fragmentation and inefficiency remained that impacted on Australia’s attractiveness as a preferred location for clinical trials.

In 2018, the Commission commenced work on behalf of the Australian Government Department of Health (the Department) and all states and territories to deliver the Governance Framework.

The Governance Framework aligns with the Commission’s existing National Safety and Quality Health Service (NSQHS) Standards (second edition) for hospital accreditation and the National Model Clinical Governance Framework.

The actions within the Governance Framework align with the actions in Clinical Governance Standard and Partnering with Consumers Standard of the NSQHS Standards which are already embedded in all public and private hospitals and day procedure services. 

It is anticipated that, embedding clinical trial services into routine practices of health service organisations under the NSQHS Standards will deliver measurable operational efficiencies across multiple therapeutic areas delivering clinical trial services. These include optimising organisational strategic planning to deliver clinical trial services and more efficient trial operations such as:

  • Pre-trial assessment of a trial site (trial site selection, feasibility assessment)
  • Pre-recruitment activities (ethical and local site specific assessment review and approval time frames)
  • Recruitment activities and trial management
  • Workforce training and engagement
  • Trial related business and financial management.

This approach:

  • Strengthens governance arrangements for clinical trial services 
  • Provides clarity to those responsible for delivering clinical trials, including governments, health services, hospital administrators, clinicians, trial sponsors and patients 
  • Reduces duplication and increases efficiency, cohesion and productivity across the clinical trials sector. 

Development of the National Clinical Trials Governance Framework

Development of The National Clinical Trials Governance Framework (Governance Framework) was underpinned by a literature review, mapping exercise of national regulation and legislation and jurisdictional legislation, polices and processes with which clinical trials must comply and, national consultation.

From September 2020 to March 2021, the Commission conducted a pilot implementation of the Governance Framework in 33 health service organisations nationally.

The aim of the pilot was to familiarise the clinical trial workforce with the accreditation process and to assess the capacity of each health service organisation to meet the actions within the Governance Framework using a maturity scale.

Economic evaluation of investigator-led clinical trials

In 2016, the Commission engaged the Australian Clinical Trials Alliance, in partnership with Quantium Health Outcomes, to evaluate the overall health and economic impact of investigator-initiated clinical trials conducted by networks.

Governments are increasingly looking to foster greater coordination and integration between safety and quality and research activities to build self-improving models of health care. As a result, there is a growing need to determine appropriate strategies to support high-quality public-good clinical trials as an integral part of the healthcare quality, safety and value agendas in Australia.

This project was intended to support evidence-based decision-making and is closely linked to the Commission's broader strategic priorities.


National launch of the Governance Framework and webcast video

The Governance Framework was launched by Dr Brendan Murphy, Secretary of the Australian Government Department of Health, on 24 May 2022 at the annual ARCS Conference.

The launch of the Governance Framework provided the opportunity to communicate the benefits of the Governance Framework for the clinical trials sector and the community more broadly. Individuals who participated in the development and pilot of the Governance Framework, who will also have a key role in implementing the Governance Framework in their organisations, accompanied Dr Murphy in the launch: 

  • Professor Erwin Loh, Group Chief Medical Officer, St Vincent’s Health Australia  
  • Ms Nicole Rasmussen, Director, Patient Safety and Improvement, Alfred Health
  • A/Professor Lewis Campbell, Staff Specialist Intensive Care Unit, Royal Darwin Hospital
  • Ms Sue Brew, Clinical Trial Coordinator, Canberra Hospital
  • Ms Anne McKenzie AM, Consumer Advocate
  • Ms Helen Aunedi, Country Head, Country Clinical Operations, Roche Australia Pty Ltd
  • Professor Anne Duggan, Chief Medical Officer, Australian Commission on Safety and Quality in Health Care.