Calvary Mater Newcastle’s Medical Oncology Research (MOR) Trials Unit is the first organisation in New South Wales to be assessed as meeting the requirements of the NSW Health Clinical Trials Quality Recognition Scheme.

The Scheme, an initiative of the Office for Health and Medical Research, recognises and promotes excellence in the conduct of clinical trials across the state.

Under the Scheme, clinical trial sites are evaluated against five key standards to ensure the delivery of high-quality and safe trial practices. These standards include strong clinical governance, robust quality systems, ongoing risk assessment and management, experienced research staff for clinical trials, and adequate infrastructure and resources to support trials and respond to medical emergencies.

To receive accreditation, sites must undergo a desktop review to demonstrate compliance, followed by an onsite assessment.

The MOR Trials Unit at Calvary Mater Newcastle originally participated in a pilot for sites undertaking Phase 1 research and was among the first to undergo formal assessment under the new scheme.

Phase 1 clinical trials test a new intervention for the first time, use a small number of participants (between 20 and 80), determine a safe dosage range and identify side effects.

As the major cancer centre for cancer clinical trials in the Hunter, the MOR Trials Unit has been delivering clinical trials for all types of cancer for more than 30 years.

The multidisciplinary team comprises experienced investigators, dedicated Phase 1 staff specialists, coordinators, data managers, and specialists in ethics, finance, and laboratory operations. The unit is also supported by a dedicated Clinical Trial Pharmacy team and includes early-phase research. The MOR Trials Unit opens approximately 30 new trials each year, bringing even more opportunities for the people of the Hunter.

Calvary Mater Newcastle Medical Oncology Senior Staff Specialist, Dr Janine Lombard, said the recognition was a credit to the hard work of the MOR Trials Unit.

“This accreditation is a proud milestone for our team. It validates the rigorous processes we have in place and reflects our deep commitment to delivering safe, high-quality research that benefits cancer patients in our region and beyond,” Dr Lombard said.

“We pride ourselves in being able to offer a broad range of trial opportunities for our patients without the need to travel to Sydney or other clinical trial sites.”

“Calvary Mater Newcastle offers trials ranging from first in Human Studies through to Phase 4 and registry trials. We have recently expanded our capacity to perform studies investigating new oncological therapies by employing two medical oncology staff specialists purely for the First in Human and Phase 1 clinical trials.”

Calvary Mater Newcastle Director of Medical Services, Dr Ralph Gourlay, congratulated those involved in achieving the recognition.

“This accreditation reflects the dedication, expertise, and commitment of our entire MOR Trials Unit to maintaining the highest standards in cancer research and patient care.”