Abstract

The notion of a learning healthcare system (LHS) is gaining traction to advance the objectives of high-quality patient-centred care. Within such a system, real-world data analysis, clinical research and health service research are core activities of the health system. To support the transition to an LHS, the Australian Government is implementing the National Clinical Trials Governance Framework, which extends health service accreditation standards to the conduct of clinical trials. This initiative encourages the integration of clinical trials into clinical care and the fostering of a culture of continuous improvement. However, implementing this initiative may prove challenging if health system leaders, clinicians and patients fail to recognise the value of clinical trials as a core health system activity. In this article we describe the enduring value of clinical trials and how the COVID-19 pandemic has enhanced their value by addressing longstanding deficiencies in the way trials are conducted. We also summarise best-practice advice on the embedding of trials into routine health care to enable their integration into health system operations. What is known about this topic? Many healthcare organisations seek to transition to a learning health system. In Australia, National Safety and Quality Health Service Standards, which support the embedding of clinical trials as a core health system activity, have been implemented to catalyse the move. What does this paper add? Because there is little practical advice on how to embed clinical trials into health system operations, this paper summarises best practice. It also provides a rationale for embedding trials as a core health system activity, because the creation of a strong research culture is an important determinant of success. What are the implications for practitioners? The successful transition to an LHS would significantly advance the goals of value-based care.

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