National Clinical Trials Governance Framework

The Commission, on behalf of all jurisdictions, developed the National Clinical Trials Governance Framework (Governance Framework) as the first step towards a nationally consistent approach to the accreditation of health services for the conduct of clinical trials.

The National Clinical Trials Governance Framework

Jurisdictional endorsement of the National Clinical Trials Governance Framework (Governance Framework) and recommendations for implementation

In February 2022, all jurisdictions agreed to implement the Governance Framework in health service organisations as an embedded approach (as clinical research is core health service business) under the Australian Health Service Safety and Quality Accreditation (AHSSQA) Scheme. That is, health service organisations will be assessed concurrently for clinical and corporate services and clinical trial service provision.

To give health service organisations time to implement the Governance Framework, for the first three-year accreditation cycle, they will be assessed against a maturity scale. That is, health service organisations will be assessed as either having Established systems, Growing systems, or Initial systems in place to meet the National Safety and Quality Health Service (NSQHS) Standards (as provided in the Governance Framework) for clinical trial service provision.

Beyond the first three-year accreditation cycle, health service organisations will transition fully to the assessment of their clinical trial services under the AHSSQA Scheme, and be assessed as either having met or not met the actions within the NSQHS Standards Clinical Governance Standard and Partnering with Consumers Standard (as provided in the Governance Framework) and receive 60 business days to remediate.

Implementation will commence in early 2023, in alignment with assessment of health service organisations to the NSQHS Standards. 

The Governance Framework is recognised as a significant reform for the clinical trials sector. The Governance Framework embeds clinical trials into routine health service provision and strengthens the clinical and corporate governance arrangements for governments, hospital administrators, health services, private companies, trial sponsors and trial investigators that deliver clinical trials. Importantly, it will do so in a way that will reduce duplication and increase efficiency, cohesion and productivity across the clinical trials sector.

The Australian Commission on Safety and Quality in Health Care (the Commission) will update the supporting resources to implement the Governance Framework, and will continue to provide advice to health services through the Safety and Quality Advice Centre.


National Clinical Trials Governance Framework implementation workshops

Join the Commission team as they deliver workshops to assist you implement the Governance Framework:

  • 15 September 2022 from 10:00am to 11:30am
  • 13 October 2022 from 12:00pm to 1:30pm
  • 10 October 2022 from 2:30pm to 3:30pm
  • 8 December 2022 from 10:00am to 11:30am

Register here to attend a workshop

The Commission has updated the resources for health services to support implementation of the Governance Framework.

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.


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 1 September 2020 – March 2021, the Commission conducted a pilot implementation of the Governance Framework in thirty-three (33) health service organisations nationally. Consolidated findings from the pilot assisted in the refinement of the Governance Framework and supporting resources. 

Watch this video to understand what accreditation to the Governance Framework means for the clinical trials workforce.

You can find further information on the Governance Framework on the resources page.

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. 


What is a clinical trial?

Clinical trials provide early access to innovative treatments and interventions for patients, and improve the overall standard of medical care provided in Australian hospitals through the uptake of evidence into practice. Data suggest that improved outcomes for patients participating in clinical trials are due in part to the increased clinical surveillance a trial provides and greater clinician adherence with evidence-based care. 

A clinical trial is any research study that prospectively assigns human participants or groups of humans to one or more health-related interventions to evaluate the effects on health outcomes.[1] Clinical trials include but are not limited to:

  • Surgical and medical treatments and procedures
  • Experimental drugs and diagnostics[2]
  • Biological products
  • Medical devices
  • Health-related service changes
  • Health-related preventative strategies
  • Health-related educational interventions.

All trials undergo rigorous evaluation to make sure that the intervention being tested is effective, safe and feasible for use more broadly in the community. 

Clinical trials generate evidence to inform best-practice ways of providing care and treatment to patients. A thriving clinical trials environment is essential for a robust and self-improving healthcare system.

  1. World Health Organisation - http://www.who.int/topics/clinical_trials/en/
  2. In the Australian context, this includes novel treatments and interventions

Self–improving health system

Self-Improving Health System

What is clinical trial governance?

Governance is the set of relationships and functions established by a health service organisation or trial service between its state or territory department of health, governing body, executive, workforce, patients, consumers, and other stakeholders to ensure good clinical trial service provision.

Clinical trial service governance is an integrated component of the corporate and clinical governance of health service organisations and trial sites. It ensures that everyone, including frontline trial investigators undertaking clinical trials and members of governing bodies such as Boards, is accountable to patients and the community for assuring the delivery of clinical trials is of high quality, integrated into clinical care and continuously improving.

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.