Clinical trials are studies that explore the impact of new or existing approaches to health care. Given the valuable insights that they offer, they are an important component of a ‘self-improving healthcare system’.
Clinical Trials aims
They generate evidence to inform best-practice ways of providing care or treatment to patients. The outcomes of clinical trials can provide evidence that leads to either:
- The adoption or continuation of effective treatment and care, or
- The cessation of ineffective interventions.
The Clinical Trials Governance Framework aims to make Australia a preferred location for trial sponsors by improving quality, efficiency and timeliness of clinical trials.
A self-improving healthcare system
Clinical Trials Governance Framework
The Commission is developing a national Clinical Trials Governance Framework as a first step towards nationally consistent accreditation of health services undertaking clinical trials in Australia.
The Commission has been engaged by the Australian Government Department of Health (the Department) on behalf of the states and territories to deliver the Clinical Trials Governance Framework by mid-2019.
The project stems from recognition by all Health Ministers that, while states and territories 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 Clinical Trials 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 National Clinical Trials Governance Framework align with the actions in Standards 1 and 2 of the NSQHS Standards which are already embedded in all public and private hospitals and day procedure services. Notably, more than half the actions within the NSQHS Standards 1 and 2 apply to clinical trial services.
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 (HREC submission to approval time frames, and local site specific assessment review time frames)
- Recruitment activities and trial management
- Workforce engagement
- Trial related business and financial management.
- 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.
Consultation on the National Clinical Trials Governance Framework
Throughout February and March 2019 national consultation on the draft National Clinical Trials Governance Framework was undertaken through a series of 12 workshops held in Sydney, Brisbane, Townsville, Melbourne, Adelaide and Perth and, via video conference with participants in the Northern Territory. Written submissions were also invited and more than 41 written submissions were received.
The Commission is in the process of finalising the National Clinical Trials Governance Framework following consultation, and will progress the final version to the Australian Health Ministers Advisory Council later this year. The Commission intends to pilot the National Clinical Trials Governance Framework in a number of hospitals/day procedure units throughout 2020 (an Expression of Interest will be circulated by the Commission regarding this in due course).
In-sights gained from the pilot will inform the approach to implementation of the National Clinical Trials Governance Framework in 2021.
The Commission will communicate these next steps to health service organisations in the coming months. The National Clinical Trials Governance Framework will be available before the end of the year.
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.