Sharing Clinical Trial Data

Research with human participants generates a wealth of useful data. While the primary outcomes of a research project are published in journals, much of the data is not further used. Important research questions could be answered using previously collected Individual Patient Data (IPD) in  secondary analyses, such as through meta-analyses or using other novel approaches.

The HeSANDA (Health Studies Australian National Data Asset) initiative is delivering the infrastructure of a national health data asset that supports the sharing and reuse of health research data across Australia. Researchers can search the HeSANDA catalogue, which contains meta-data from clinical trials available for secondary use upon request. The HeSANDA Mental Health Node (MHN) is one of nine  nodes’ supported nationally by the Australian Research Data Commons (ARDC), which is led by Deakin University. The MHN will work in close collaboration with the Secure Health Data and Biosample platform (SHeBa), a state-of-the-art platform created collaboratively between Deakin University and Barwon Health for discovering, combining, accessing, and analysing health data and biosamples collected by health services, research groups and other custodians.

The MHN and SHeBa aim to accelerate research to improve the health and wellbeing of people in Australia and internationally by enabling clinicians and researchers to find, request, and work with unidentifiable health data and biosamples on a single, secure, remotely accessible platform. This will enable the secondary use of data to maximise the outputs and impact of already collected mental health data.

To learn more please visit Mental Health Node Resources

Benefits to you

  • Data sharing increases citations of the original authors, thus improving researcher
    reputations.
  • Funding bodies look favourably at data sharing practices and may increase the likelihood that
    future research grant proposals will be successful.
  • Meta-analyses are easier to produce.
  • Combining data improves sample sizes and study power.

Benefits to your institution

  • A University’s citation count can increase, thus improving the university’s reputation to the
    public and research community.
  • Data sharing promotes collaboration and resource sharing between institutions, which can
    result in future, collaborative research projects.
  • Reuse of data is economically efficient, as it reduces the waste of grant funding.
  • Secondary analysis projects are a cost-effective option for Higher Degree Research students.
  • Replicability of research findings becomes easier and more transparent.

Benefits to the community

  • Secondary analyses allow the creation of new research questions and extension of original
    findings, resulting in improved knowledge and understanding of important public health
    matters, benefiting the community as a whole.
  • The Australian Code for Responsible Conduct of Research encourages researchers to make their
    data available to other researchers.
  • Sharing data encourages better transparency in research methods and results, which can
    improve the public image and perception of scientific research.
  • Respects the generosity of human research participants, as it increases the utility of the
    data they provide and thus the value of their contribution.

 

Establishing a clinical trial for later data sharing

The MHN has developed a set of Standard Operating Procedures (SOPs) for clinical trialists who conduct
mental health research in Australia. These SOPs serve as helpful guides, providing direction for acquiring
informed consent from participants, securing ethical approval for data sharing, and guidance on data
management. By adhering to these SOPs, trialists can ensure a smooth data sharing process, leading to the
establishment of data sharing as a standard practice for future mental health related clinical trials. For
further information or assistance, please contact the Mental Health Node at mentalhealth_n@deakin.edu.au. Visit the Health Data Australia website to research the HeSANDA clinical trials catalogue at https://researchdata.edu.au/health/.

Documents for download

HeSANDA Mental Health Node – Data Sharing Standard Operating Procedures

HeSANDA Mental Health Node – ANZCTR Data Sharing Statement Instructions

HeSANDA Mental Health Node – Ethics Guidelines

MAGNET First Nations Data Sovereignty Statement