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.
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.
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 our health and medical research team.
For questions regarding accreditation please contact the Safety and Quality Advice Centre.
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