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 National Clinical Trials Governance Framework (NCTGF).
The NCTGF aligns with the Commission’s National Safety and Quality Health Service (NSQHS) Standards (second edition) for hospital accreditation and the National Model Clinical Governance Framework.
The 27 actions within the NCTGF are based upon safety and quality actions of the Clinical Governance Standard and Partnering with Consumers Standard of the NSQHS Standards which are already embedded and assessed in all public and private hospitals and day procedure services.
The intent of the NCTGF is to incorporate clinical trial services into routine practices of health service organisations under the NSQHS Standards to enhance safety and quality standards and achieve 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 and 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 clinical and corporate 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 (NCTGF) was underpinned by a literature review, mapping exercise of national regulation 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 NCTGF 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 NCTGF 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.
Committees and Advisory Groups
A series of Committees and Advisory Groups were convened to oversee development of the National Clinical Trials Governance Framework. These groups were comprised of members with relevant expertise and experience in the clinical trials sector.
National launch
The NCTGF 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 NCTGF for the clinical trials sector and the community more broadly.