Clinical Trials and Data

Our Focus

• Collaborate widely across the membership and beyond, to include affiliated partners external to the organisation, supporting approval and governance processes.

• Improve community engagement and patient access and recruitment into high quality clinical trials.

• Develop, update and strengthen our Clinical Trials and Data integration capability and capacity frameworks.

• Support and nurture clinical trial and data management sector growth, compliance, sustainability and financial return, for partners and other key stakeholders.

• Share data from our clinical trials, registries and ethics and governance processes for new knowledge and innovation to ensure better health outcomes.

• Capture technology and modern approaches to better harmonise, link, analyse and understand our data.

Projects

SPHERE has the following data driven activities currently in the pipeline:

• The Cancer Variation (CaVa) platform utilises data integration to analyse variation of cancer treatments across organisations.

• PeRson-centred Adherence Intervention Supported by Electronic medical record Data integration (PRAISED), utilises data drawn from electronic medical records in real-time to identify patients at high risk of readmission. PRAISED investigates variations in practice related to drug adherence, measuring local early readmission data to integrate administrative and clinical inputs.

• AI-ED is using artificial intelligence (AI) to promote integrated care quality for older people by reducing preventable emergency department (ED) admissions. The aim of this project is to enable older people to remain independent, functioning, and diminish disability and deterioration with the right care at the right time in the right place. It will inform early intervention approaches that empower and integrate community and primary care.

• RODE (Research and Operational Data Environment) is a distributed data platform that provides cross-jurisdictional data access. Locally built in South Eastern Sydney Local Health District (SESLHD) and eHealth NSW operated, RODE has been designed from the ground up to meet all operational, security, and governance requirements for the provision of identifiable health data for research and service management. This data platform opens up the capacity for Phase IV clinical trials and improves capacity to identify eligible clinical trial participants.

• RICH harnesses the RODE platform infrastructure to enable and monitor research collaboration activities. The technology-based RICH program will enable SPHERE members to find information on research activities and capabilities across the partnership.

For more information, contact Research Support Officer Natalie Walsh.

For more information, contact Research Support Officer Natalie Walsh.

Education, Training and Resources

SPHERE supported Education and Training resources can be searched via our Resources page.

Resource topics include:

• Good Clinical Practice (GCP)
• GCP Train the Trainer
• Introduction to HREC fundamentals
• Health Economics Workshop Sessions
• Ethics Exchange Webinar Series
• Clinical Trial Audit and Monitoring
• HREC Leaders’ Summit

See also external links:

The Australian Commission on Safety and Quality in Health Care (ACSQHC) has developed resources for health services to support implementation of the National Clinical Trials Governance Framework. See link for access to tools and resources, including webinars, fact sheets, case studies and web-based tools.

Australian Clinical Trials, an Australian Government initiative to provide information and resources to participants, healthcare providers, researchers and industry about taking part in, accessing and running clinical trials.

Australian Clinical Trials Education Centre (A-CTEC), an Australia wide, member-based education platform, hosting a comprehensive suite of evidence- based, interactive clinical trials education opportunities suitable for a range of learning needs.

Health Translation Queensland (HTQ) facilitates education and training sessions to support researchers and professional staff working in the areas of research, ethics, and research integrity and governance. See HTQ resource webpage for recordings and relevant resources from the 5^th National Human Research Ethics Conference in Nov 2024.

Health Translation Queensland has also launched an online Clinical Trials Hub, providing practical resources and tools for clinical trials teams to effectively plan, manage and track the progress of their clinical trials. The feature tool, My Clinical Trial Planner, guides teams through 4 clinical trial stages, outlining the many steps at each stage.

The IMPACCT Trials Coordination Centre supports researchers (both internal and external to UTS) to undertake high-quality clinical studies and provides clinical trial support for medications, non-pharmacological interventions and medical devices. 

UNSW’s Clinical Research Unit (CRU) is a gateway to connect and collaborate with UNSW’s ecosystem of expertise and infrastructure. The CRU aims to partner with researchers to shape the future of medicine through transformative clinical research and trials.

Australian Clinical Trials Alliance (ACTA) is the national peak body supporting and representing networks of clinician-researchers conducting investigator-initiated clinical trials, maintaining clinical quality registries, and operating clinical trial coordinating centres within the Australian healthcare system.

Health Studies Australian National Data Asset (HeSANDA) is a program of the Australian Research Data Commons (ARDC) that aims to build the national infrastructure required to support the sharing and reuse of health research data in a way that would bring value to the research community, increase the efficiency of research, and provide benefits for the health of Australia’s population. SHP and the NHMRC Clinical Trials Centre (CTC) at the University of Sydney lead the Sydney Node Project of the HeSANDA program. SPHERE members with further queries and wishing to engage in data sharing activities, please contact Research Support officer Dr Natalie Walsh for further information.