About the National Clinical Trials Governance Framework

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.

Background

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.

Research and development

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.

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.

Download the literature review and mapping exercise reports

National Clinical Trials Governance Framework Literature Review

2022

Publication, report or update

National Clinical Trials Governance Framework Mapping Exercise

2022

Publication, report or update

Download the Economic evaluation of investigator-initiated clinical trials conducted by networks: final report

Pilot Program

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.

The Commission developed case studies of health service organisations that participated in the pilot and demonstrated a successful integration of clinical trial services into existing corporate and clinical governance systems. These case studies describe the strategies used by health service organisations to implement the actions Clinical Governance Standard and Partnering with Consumers Standard, and may serve as a guide for other health service organisations in understanding what successful implementation could look like.

Download the Pilot executive summary report

Download the Pilot case studies

Alfred Health case study - National Clinical Trials Governance Framework

2022

Fact sheet or brochure

Ramsay Health Care case study - National Clinical Trials Governance Framework

2022

Fact sheet or brochure

Governance Framework Committees

The National Clinical Trials Governance Framework Committees were convened comprising members with relevant expertise and experience in the clinical trials sector.

Phase 2 Advisory Committee members (2019-2020)

The role of the Advisory Committee is to provide high level guidance and advice on the deliverables of the project and provide a point of liaison between the Commission and peer groups.

Committee member name	Committee contribution	Role, title and organisation	State
Prof Chris Brook PSM	Chair	Chair, health policy consultation, CTPRG Chair and independent expert	VIC
Prof Erwin Loh	Deputy Chair Hospital administrator	Group Chief Medical Officer, St Vincent's Health Australia	VIC
Prof Robyn Aitken	Clinical trials (clinical - nursing)	Professor of Nursing, College of Nursing and Midwifery Flinders University	SA
Ms Helen Aunedi	Industry	Country Head, Country Clinical Operations, Roche Australia Pty Ltd.	National
Ms Jillian Barr	National Health and Medical Research Council (NHMRC)	Director, Ethics and Integrity; Research, Quality and Priorities Branch, NHMRC	Commonwealth
Mr Adrian Bootes	Commonwealth Department of Health	Assistant Secretary, Prescription Medicine Authorisation Branch, Therapeutic Good Administration, Commonwealth Department of Health	Commonwealth
Prof Nicholas Brown	Representative of Universities Australia	Professor of Allied Health Research, University of Canberra	National
Ms Allyson Essex	Commonwealth Department of Health	Assistant Secretary, HERD Health Economics and Modelling Branch	Commonwealth
Dr Jodi Glading	Clinical Trials Project Reference Group (CTPRG)	Deputy Chief Medical Officer, Health Professional Policy and Advisory Services Group, Tasmanian Department of Health	TAS
Dr Robert Herkes	Chief Medical Officer	Australian Commission on Safety and Quality in Health Care	National
Ms Elizabeth Heyer	Clinical trials research coordination	Clinical trials Coordinator, Townsville Hospital and Health Services	QLD
Sue Jenkins-Marsh	Clinical trials research coordination	Manager, Townsville Research Education, Support and Administration Unit, Townsville Hospital and Health Services	QLD
Ms Anne McKenzie AM	Consumer representative	Head of the WA Consumer and Community Health Research Network	WA
Ms Terrie O' Brien	Commonwealth Department of Health	Director, Clinical Trials Section, Health and Medical Research Office, Health Economics and Research Division, Department of Health	Commonwealth
Dr Antonio (Tony) Penna	Clinical Trials Project Reference Group (CTPRG)	NSW CTPRG Representative. Executive Director, Office for Health and Medical Research, NSW Ministry of Health	NSW
Mr Ian Pieper	Expertise in ethics and governance process	Director, Research Ethics and Governance Office, ACT Health	ACT
Ms Nicole Rasmussen	Safety and Quality Officer	Director, Patient Safety and Improvement at Alfred HeaIth	VIC
Bernadette Swart	Research Governance Officer	Manager, CALHN Research Services, SA Health	SA
Angela Watt	Research Governance Officer	Director Research Governance and Ethics, Melbourne Health Office for Research, Royal Melbourne Hospital	VIC
Dr Margaret Way	Safety and Quality Officer	Executive Director Innovation, Quality, Research and Education at Sunshine Coast Hospital and health Service	QLD
Prof John Zalcberg	Representative of investigator-led trials	Chair, Australian Clinical Trials Alliance (ACTA)	National
Dr Sara Watson	Research Governance Officer	Director, Clinical Safety and Quality Office of the Chief Executive Officer	NT
Jessica Southwood	Clinical trials research coordination	Statewide Research Coordinator, Office of Research, Department of Health & Wellbeing	SA
Associate Prof Bhavini Patel	Research Governance Officer	Executive Director, Medicines Management, NT Department of Health	NT

Steering Committee members (2018-2019)

The Steering Committee set out to:

Support delivery of the project in line with the requirements of the Commission and the expectations of the Department of Health
Provide advice on the development of the National Clinical Trials Governance Framework and high level implementation plan
Facilitate engagement with peer groups about the project

Committee member name	Committee contribution	Role, title and organisation	State
Prof Chris Brook PSM	Chair	Chair, health policy consultation, CTPRG Chair and independent expert	VIC
Assoc. Professor Robyn Aitken	Clinical trials (clinical - nursing)	Director, Collaborative Academic Health Science Research	NT
Ms Helen Aunedi	Industry	Country Head, Country Clinical Operations, Roche Australia Pty Ltd.	National
Ms Jillian Barr	National Health and Medical Research Council (NHMRC)	Acting Executive Director, Research, Quality and Priorities Branch, NHMRC	Australian Government
Professor Ben Canny	Universities Australia	Head, School of Medicine College of Health and Medicine University of Tasmania	National
Dr Jodi Glading	Clinical Trials Project Reference Group (CTPRG)	Deputy Chief Medical Officer, Department of Health and Human Services, Tasmania	TAS
Dr Robert Herkes	Chief Medical Officer	Australian Commission on Safety and Quality in Health Care	National
Ms Erica Kneipp	Australian Government Department of Health	Assistant Secretary, Office of Health and Medical Research, Australian Government Department of Health	Australian Government
Professor Chris Levi	Clinical trials (clinical - physician)	Executive Director, The Sydney Partnership for Health, Education, Research and Enterprise (SPHERE)	NSW
Professor Erwin Loh	Hospital administrator	Group Chief Medical Officer and General Manager Clinical Governance, St Vincent's Health Australia	National
Ms Anne McKenzie AM	Consumer representative	Head of the WA Consumer and Community Health Research Network	WA
Dr Grant Pegg	Therapeutic Goods Administration	Director, Experimental Products Section, Pharmacovigilance and Special Access Branch	Australian Government
Dr Antonio (Tony) Penna	Clinical Trials Project Reference Group (CTPRG)	NSW CTPRG Representative. Executive Director, Office for Health and Medical Research, NSW Ministry of Health	NSW
Mr Ian Pieper	Expertise in ethics and governance process	Ethics Manager Research Ethics and Governance Office, ACT Health Directorate	ACT
Ms Susan Richmond	Clinical trials research coordination	Research Officer, Clinical Trials Unit, James Cook University, Cairns	QLD
Prof Steven Webb	Representative of investigator-led trials	Senior Staff Specialist in Intensive Care Medicine at Royal Perth Hospital and a Professor of Critical Care Research in the School of Public Health and Preventive Medicine at Monash University.	WA

Additional key stakeholders

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

National launch of the Governance Framework

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 provided the opportunity to communicate the benefits of the Governance Framework for the clinical trials sector and the community more broadly.

Contact us

For questions regarding implementation and feedback on the National Clinical Trials Governance Framework please contact HMR@safetyandquality.gov.au.

For questions regarding accreditation please contact the Safety and Quality Advice Centre via AdviceCentre@safetyandquality.gov.au or 1800 304 056

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