Resources for the National Clinical Trials Governance Framework
The Australian Commission on Safety and Quality in Health Care (the Commission) has developed resources for health services to support implementation of the National Clinical Trials Governance Framework (Governance Framework).
These fact sheets explain the National Safety and Quality Health Service (NSQHS) Clinical Governance Standard Partnering with Consumers Standard and identify the roles and functions of the governing body, managers (clinical and non-clinical), principal investigators, clinical trials workforce, accrediting agencies and consumers.
The Commission has developed case studies of participating health service organisations that 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.
The Commission has developed the following web-based tools to assist health services monitor their clinical trial service operations and self-assess their capacity to meet the actions within the NSQHS Standards, as provided in the Governance Framework:
This self-assessment tool assists health services assess their capacity to meet the actions in the Governance Framework. The tool enables health services to:
Determine whether they meet the actions
Document the evidence that demonstrates each action has been met
Create an action plan of any tasks to meet the actions, including allocating a person responsible for completing the tasks.
Actions within the Governance Framework are aligned with the NSQHS Clinical Governance Standard and Partnering with Consumers Standard. Speak with your hospital quality officer about the systems and processes currently in place to meet the actions within the NSQHS Standards and use the tool to assess your clinical trial service.
Operational metrics tool
The operational metrics tool enables the workforce within trial units, clinical departments, hospitals and health networks to report on their clinical trial service operations. This information enables health service organisations to review their clinical trial services operating in multiple departments using a series of automated reports.
All information provided by registrants is kept strictly confidential. The information is held electronically in restricted access files.
No information will be reported that might identify a health service organisation without their permission. The Commission is bound by its privacy policy.
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 diagnostics2
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.
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.
In 2018, the Commission undertook a project to develop the National Clinical Trials Governance Framework (the Governance Framework) on behalf of all states and territories, as a first step towards accrediting health services undertaking clinical trials. The Governance Framework is a key element of the then Council of Australian Governments Health Council revitalised clinical trials agenda under the Encouraging More Clinical Trials in Australia initiative.
The aims of the Governance Framework are to support the delivery of high-quality clinical trial services and to ensure that clinical trials are conducted in a safe environment.
Under the Australian Health Service Safety and Quality Accreditation (AHSSQA) Scheme, it is intended the Governance Framework will strengthen governance arrangements for hospital administrators, health services that deliver clinical trials, private companies, trial sponsors and trial investigators. Specifically, the Governance Framework supports health services to improve trial start-up times, optimise pre-approval and recruitment time frames and improve collaboration across health service organisations.
The Governance Framework describes the actions that are essential for health service organisations to achieve integrated corporate and clinical governance systems for clinical trial services.
The cost of delays in trial start-up impact on clinical trial budgets and are frequently related to strategic and operational barriers. Improved organisational governance of trial services enables health administrators to oversight trial operations including (complex) contract negotiation (including financial schedules), use of national forms and standard contracts, determine work force arrangements and optimise organisational strategic planning to deliver clinical trial services. It is anticipated that, accreditation to the actions within the Governance Framework will remove barriers to the following clinical trial processes.
Trial site feasibility assessment
Timely ethical and site-specific assessment approval timeframes
Participant screening and recruitment activities
Trial management
Workforce planning and staff training
Trial related financial management and reporting.
Systems and processes currently in place in health service organisations that underpin strategic planning to deliver clinical trial services include: organisational leadership; policies and procedures; risk management; incident management and open disclosure; workforce safety and quality training and infrastructure to deliver clinical trials.
The Commission has developed resources to support health services implement the Governance Framework. Once implemented, health service administrators will have visibility of trial related activity within their organisation. Clinical trial operations will be measured and reported by trial; trial site; health service organisation and jurisdiction. Measures of operational efficiency will align with the National Aggregate Statistics (NAS) currently reported only at the jurisdictional level for public health organisations.
Health service organisations accredited to the National Safety and Quality Health Service (NSQHS) Standards conducting clinical trials will be assessed against the actions in the Governance Framework.
For health service organisations that are already accredited to the NSQHS Standards, the accreditation process will remain unchanged. However, assessment against the actions in the Governance Framework will be included.
Health service organisations will continue to select their accrediting agency, from among approved agencies, to assess their performance.
The Governance Framework builds on the NSQHS Standards, providing information about the roles and functions of those people involved in providing clinical trial services within a health service organisation or trial site. The Governance Framework advises on the actions and suggests strategies a health service organisation or trial site may implement to meet the actions. Examples of evidence a health service organisation may provide to accreditation assessors to demonstrate they have met the actions are also available in the Governance Framework.
Accreditation of clinical trial services under the AHSSQA embeds clinical trials into routine health service provision, optimises organisational strategic planning to deliver clinical trial services and delivers measurable efficiencies in trial operations including:
Trial site feasibility assessment
Pre-recruitment activities (ethics and local site review and approval timeframes)
Participant recruitment
Trial management
Workforce management
Trial related financial management.
This approach intends to:
Strengthen governance arrangements for clinical trial services
Provide clarity to those responsible for delivering clinical trials, including patients, clinicians, trial sponsors and hospital administrators
Reduce duplication and increase efficiency, cohesion and productivity across the clinical trials sector.
In April 2016, the then Council of Australian Governments Health Council noted that, while jurisdictions have worked to improve the environment for clinical trials, issues of fragmentation and inefficiency remain that impact on Australia’s attractiveness as a preferred location for clinical trials.
The then Australian Health Ministers’ Advisory Council (AHMAC) was tasked to work up options for the development of models of best practice to organise sites and to improve administered efficiencies, better engage sponsors and improve trial start up times. The full AHMAC response was developed on its behalf by the (now) Clinical Trials Project Reference Group (CTPRG) and included a recommendation for a national Governance Framework. The CTPRG is the expert advisory sub-group tasked with progressing the revitalised clinical trials agenda.
In 2017, the Commission was engaged by the Australian Government Department of Health on behalf of all states and territories to undertake a project to develop the Governance Framework under the Encouraging More Clinical Trials in Australia initiative. In April 2018, an expert Steering Committee was convened to advise on the development of the Governance Framework which was underpinned by a literature review; a mapping exercise of national and jurisdictional regulation, legislation, clinical trial polices and processes and national sector-wide consultation.
The Governance Framework is the first step towards a nationally consistent accreditation of health service organisations undertaking clinical trials and is highly anticipated by the jurisdictions and the clinical trials sector.
The Governance Framework and user guide provides detailed information and strategies to assist health service organisations with implementing the improvements required by the Governance Framework. Suggested strategies to meet the actions within the Governance Framework, and examples of evidence a health service might provide to demonstrate they have meet the actions are also provided.
The Commission has also developed supporting resources (including a self-assessment tool, case studies, fact sheets, video tutorial and online operational metrics tool) to support implementation.
The Commission has a NSQHS Standards Advice Centre available for support and, if required, mediation between health service organisations and accreditation agencies during assessment. Support will be provided by telephone 1800 304 056 and email accreditation@safetyandquality.gov.au.
Additional support will be provided by the Commission to health service organisations throughout the first assessment cycle.
For the first assessment cycle, clinical trials services will be assessed using a maturity scale for each action to provide a description of success. That is, the Governance Framework recognises that health services are at different stages of maturity in implementation of the actions. It is expected that improvements should be achievable over a planning cycle of three years.
The maturity scale is a guide for progressive improvements in each of the criteria within the NSQHS Standards for trial services including demonstration that initial systems are in place; the health service organisation is developing systems and the health service organisation has established systems.
Figure 1: Maturity scale for health service organisation assessment
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.
One of the underpinning principles of the Governance Framework is equity. That is, health service organisations provide equitable access for the community to commercially sponsored clinical trials and investigator-initiated clinical trials in a timely manner.
The Governance Framework also provides guidance for health service organisations when they are the trial sponsor. For investigator-initiated trials, the health service organisation or trial site that is the approving authority may also be the trial sponsor. In such cases, the governing body ensures that it separates its responsibilities as a trial sponsor from its responsibilities as a trial site and ensures that the requirements of sponsorship can be met.
Clinical trial networks and ARHTCs could work with their member organisations to build capacity in a number of ways including, but not limited to: clinical trial education and training for the workforce and consumers; providing advice and support to trial investigators and researchers on good clinical trial practice relating to protocol development; data management and analytics; report writing; navigating ethical processes; participant recruitment and project management.
AHRTCs could also support health service organisations in the review of clinical trial outcomes and contribute to guideline development and evidence translation into clinical practice.
