Most significant change to Australian clinical trials delivery

Pharma News: ARCS Australia welcomes today’s release of the National Clinical Trials Governance Framework by the Australian Commission on Safety and Quality in Health Care (the Commission). The framework will be piloted from March – May 2020. The Commission is seeking expressions of interest for the pilot by 13 March 2020.

The framework describes the actions that are essential for health service organisations to achieve integrated corporate and clinical governance systems for clinical trial service delivery. It strengthens governance arrangements and provides clarity to ensure good clinical trial service provision. The framework is based on national consultation and underpinned by best practice principles based on existing clinical trial regulations.

Dr Shanny Dyer, CEO of ARCS Australia, said: “The framework is the most significant change to how clinical trials are delivered in Australia since the introduction of the Clinical Trial Notification scheme.

“The aim of the framework is to support better safety and quality to improve health outcomes for patient and trial participants. It sets out everyone’s mandatory responsibilities and accountabilities and assures that the delivery of clinical trials is of high quality, integrated into clinical care and continuously improving.

“ARCS Australia has supported the sector by providing high quality accredited training on international standards and GCP as well as specific training on all aspects of conducting clinical trials. We will develop specific training linked to the framework to ensure appropriate application and guidance around the standard as the framework is embedded,” concluded Dr Dyer.

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Clinical trials are an important contributor to the Australian economy contributing to the GDP, attracting overseas investment, and supporting skills development and retention. The international clinical trials sector is predicted to grow significantly over the next decade and it is important for Australia to have policies and systems in place to capitalise on this growth.

In March 2019 ARCS Australia provided a detailed submission to the review of the framework which is accessible on the website to ARCS members only.

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