Clinical trials are studies that explore the impact of new or existing approaches to health care. 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 the adoption or continuation of effective treatment and care, or the cessation of ineffective interventions. Given the valuable insights that clinical trials offer, they are an important component of a ‘self-improving healthcare system’ (see Figure 1).
A self-improving healthcare system
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 will align 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 (2017). This approach strengthens governance arrangements for clinical trials, and provides clarity to those responsible for delivering clinical trials, including governments, health services, hospital administrators, clinicians and others. An important aim is to reduce duplication and increase efficiency, cohesion and productivity across the clinical trials sector.
The Clinical Trials Governance Framework aims to make Australia a preferred location for trial sponsors by improving quality, efficiency and timeliness of clinical trials.