Research Australia welcomes new accreditation for clinical trials, while recognising strain on overburdened health system

A thriving clinical trials environment is essential for a robust healthcare system. The Australian Commission on Safety and Quality in Health Care has advised stakeholders that from March 2023 all heath service organisations conducting clinical trials will need to implement the National Clinical Trials Governance Framework in alignment with the National Safety and Quality Health Service (NSQHS) Standards.

To support the delivery of high-quality clinical trials that promote the best possible outcomes for patients, the Commission, on behalf of all jurisdictions, has developed the National Clinical Trials Governance Framework as the first step towards a nationally consistent approach to the accreditation of health services for the conduct of clinical trials.

The Governance Framework is recognised as a significant reform for the clinical trials sector. It embeds clinical trials into routine health service provision and strengthens the clinical and corporate governance arrangements for governments, hospital administrators, health services, private companies, trial sponsors and trial investigators that deliver clinical trials. Importantly, it will do so in a way that will reduce duplication and increase efficiency, cohesion and productivity across the clinical trials sector.

As the peak body for the entire Australian Health and Medical Research pipeline, Research Australia wants all Australians to receive the best medical care from initial research, to clinical trials and through to commercialisation of all medical products.

Nadia Levin, CEO of Research Australia told Health Industry Hub “We believe that introduction of the National Clinical Trials Governance Framework will have positive outcomes for healthcare in Australia.

“Locally and in the short term we think that having agreed frameworks and processes, without removing governance or clinical independence, will ensure improved consistency across clinical trials. Internationally and in the medium to long term, we believe that it will make us an even more attractive destination for more clinical trials to take place.”

She added “However, we appreciate that our current health system has faced significant challenges and unforeseen challenges in the past three years. COVID 19 has wreaked havoc on our health care system. Significant workforce issues such as burn out, lack of retention and the inability to recruit new staff have placed further strains on our already overburdened healthcare infrastructures. Therefore we understand the concerns of public and private hospitals, day procedure services and public dental services facilities regarding the additional time, effort and work that is required to prepare for the implementation which is scheduled to commence in March 2023. We encourage all stakeholders from across the pipeline to fine tune this process so that it works cohesively for all participants and improves health comes for all Australians.”

For the first three-year accreditation cycle, health service organisations will be assessed against a maturity scale as either having Established systems, Growing systems, or Initial systems in place to meet the NSQHS Standards for clinical trial service provision using the Governance Framework.

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