HeSANDA Clinical Trials

The Challenge

The Health Studies Australian National Data Asset (HeSANDA) program is building national infrastructure to support the sharing and reuse of sensitive health research data. It is part of the ARDC People Research Data Commons initiative, which is developing, operating and coordinating national-scale capabilities to support digital health research and translation.

Enabling access and reuse of clinical trials data allows for better insights about the effectiveness of health interventions and therapies, which allows for health guidelines and treatments to be improved as exemplified by the collaborative response to the COVID-19 pandemic.

While the potential benefits are significant, as is the case with most health data, the sharing and reuse of clinical trials data are limited by the diverse approaches to data governance and management used by trials in Australia.

The Response

Our HeSANDA Clinical Trials projects are delivered in partnership with the Australian clinical trials community to develop and implement national data standards. 

Consultations with the research community and key stakeholders identified priorities, requirements, and guiding principles for a new national research infrastructure.

Based on this, we established partnerships with research institutions, organisations and other stakeholders involved in clinical trials research around Australia. We work together to establish national build national capability in the 3 key areas:

Who Will Benefit

Researchers need to access health research data for their analyses and to inform clinical guidelines and practices. Issues such as patient privacy as well as differing jurisdictional requirements and business practices can make providing that access difficult and sometimes impossible.

The goal of the infrastructure projects is to align and develop the ways in which data is managed to make it easier for data custodians and researchers to share data and collaborate.

The Partners

ARDC has established a network of 9 infrastructure nodes representing 72 research organisations, covering the majority of Australia’s states, territories, and health researchers. These organisations will work together to deliver coherent data practices and coordinated data services at a national scale.

Outcomes

The outcomes of this project currently include:

• Health Data Australia – a national platform where researchers can discover and request access to clinical trials data held across the HeSANDA network
• guidance for clinical trial data sharing policies and agreements
• a participant consent form for data sharing (produced in partnership with the CT:IQ Informed project)
• a national metadata standard for clinical trials data discovery
• a range of skills resources and other guides to support clinical trials data sharing.

Key Resource

Learn more about HeSANDA, its value, how it works and the HeSANDA network from this flyer.