Outstanding audit result supports Grampians Health’s vision for dedicated Clinical Research Centre

Grampians Health is building on its strength in regional clinical research, with plans for a dedicated Clinical Research Centre supported by an outstanding audit result from Australia’s Therapeutic Goods Administration (TGA).

The Grampians Health Clinical Trials Unit achieved an exceptional result following a comprehensive two-day TGA audit, with no findings or recommendations for improvement.

The audit, conducted in June by the TGA within the Australian Government Department of Health, Disability and Ageing, examined the unit’s governance, quality systems, regulatory compliance and participant processes for Phase 1 clinical trials.

Clinical trials are carefully planned research studies that develop and test new medicines, treatments and approaches to care. They give eligible patients opportunities to access innovative therapies while contributing to discoveries that may improve healthcare for future generations.

Phase 1 trials are the first stage of testing promising new medicines and treatments in people. They help researchers assess safety, determine appropriate doses and understand how a treatment behaves in the body before it progresses to larger studies.

As one of only a small number of regional health services in Australia delivering Phase 1 clinical trials, Grampians Health plays an important role in bringing leading research and emerging treatments to rural and regional communities.

Grampians Health Chief Medical Officer Professor Matthew Hadfield said the TGA result provided independent assurance of the quality and maturity of the health service’s clinical trials program.

“An audit outcome with no findings or recommendations is an exceptional result and a powerful endorsement of the expertise of our people, the strength of our governance and the quality of our clinical trials program,” Professor Hadfield said.

“It demonstrates that highly complex and tightly regulated clinical research can be delivered safely and successfully in regional Victoria.

“This gives us a strong foundation for the next stage of our research growth, including the development of a dedicated Clinical Research Centre.”

Grampians Health currently hosts approximately 100 active clinical trials, making it the largest clinical trials unit in western Victoria. Its research program covers all four phases of clinical trials and spans clinical areas including oncology, cardiology, haematology, neurology, anaesthetics, renal medicine and intensive care.

Professor Hadfield said expanding the health service’s research capabilities would strengthen patient care while supporting the attraction and retention of highly skilled staff.

“A dedicated Clinical Research Centre will help bring more trials, research partnerships and emerging treatments to our region,” Professor Hadfield said.

“For our communities, this means greater opportunities to participate in research and access innovative care closer to home.

“It will also help Grampians Health attract and retain talented clinicians, researchers and healthcare professionals who want to work at the forefront of medicine, contribute to new discoveries and improve care for rural and regional patients.”

Grampians Health Clinical Trials Manager Rebecca Gurnett said the audit outcome reflected a strong culture of quality, integrity and participant-centred care across the organisation.

“Phase 1 trials are among the most highly regulated forms of clinical research, so achieving this result is a significant accomplishment,” Ms Gurnett said.

“It reflects the skill and dedication of our clinical trials team, as well as the contribution of staff across Grampians Health who support safe, ethical and high-quality research.

“Most importantly, it gives patients, families, research partners and the wider community confidence that our trials are being conducted to the highest standards.”

The planned Clinical Research Centre will provide purpose-designed facilities to support the continued growth of Grampians Health’s research program. It will help increase trial activity, attract new partnerships and create more opportunities for regional patients to benefit from advances in treatment and care.

Ms Gurnett said the Centre would support Grampians Health to extend the reach and impact of its clinical research.

“People in regional communities should have the opportunity to benefit from research and emerging treatments without travelling long distances to metropolitan centres,” Ms Gurnett said.

“Growing our capability means we can give more patients that opportunity while contributing regional knowledge and experience to research that may shape healthcare in Australia and internationally.”

The Care Closer to Home Appeal was launched by Grampians Health on 29 July to raise funds for the development of the Clinical Research Centre.

To learn more or support the appeal, visit the Care Closer to Home Appeal.

To learn more about research and clinical trials at Grampians Health, visit Grampians Health Research.