Resources for Clinical Trials Data Sharing and Reuse

Last updated:

18 November 2024

Type:

Dataset, Guide, Tool / Service

Format:

Webpage, Videos
Read time: 6 minutes

Explore our resources for sharing and reusing clinical trials data, including Health Data Australia, guides and other tools.

  • Higher-degree researchers (HDRs) and PhD candidates
  • Early-career researchers (ECR)
  • Mid-career and senior researchers
  • Infrastructure providers (including research facilities)
  • Data custodians and managers
  • Digital skills trainers

After reading this page, you should be aware of:

  • the benefits of clinical trials data sharing and reuse
  • the Health Data Australia platform and its uses for secondary research 
  • guides and such other tools as forms and standards for clinical trials data sharing and reuse.

Clinical trials produce vast amounts of valuable data about the trial participants, health and responses to the interventions being studied. Beyond the original research, the data can be reused to discover new findings, inform future studies, guide clinical practice and serve teaching purposes. 

The ARDC’s Health Studies Australian National Data Asset (HeSANDA) activity is building national infrastructure to allow researchers to access and request clinical trials as well as other health studies data more easily. 

On this page, you’ll learn about the benefits of sharing clinical trials data. You’ll then find resources created through HeSANDA to support clinical trials data sharing and reuse, including:

  • Health Data Australia, an online catalogue that researchers can use to browse descriptions of Australian clinical trials and request access to the data, and guides to using the platform
  • guides and tools for setting up clinical trials for data sharing
  • a guide to metadata in clinical trials and a national metadata standard for data discovery.

Benefits of Data Sharing and Reuse

Data sharing maximises the value of Australia’s investments by coordinating research efforts and avoiding duplication. By enabling reuse of clinical data, data sharing extends the life of research, initiates collaborations and increases publication citations that collectively enhance the competitiveness of grant applications.

Data sharing fosters richer, more extensive datasets that inspire new questions and research hypotheses. These findings can help researchers make new scientific discoveries and inform clinical guidelines to support the health and wellbeing of the community. 

Learn more about the benefits of sharing clinical trials data from the following presentations at “Advancing Health Research Through Data Sharing”, a national symposium hosted in October 2023 by Health Translation SA:

Supported by Health Data Australia, an online national catalogue of Australian clinical trials data that allows researchers to discover and request data for their research, researchers can reuse and benefit from secondary clinical trials data in 4 scenarios:

  1. compiling data and evidence to answer specific research questions (evidence synthesis)
  2. using existing datasets to answer new research questions (secondary analysis)
  3. verifying the accuracy, validity and trustworthiness of scientific findings (reproducibility, replication and validation)
  4. advancing knowledge and education by leveraging existing data sets (education, training and learning).

Read and hear about data reuse in these 4 scenarios. Also read a practical guide to these data reuse scenarios.

Introducing Health Data Australia

Health Data Australia is an online, searchable, national catalogue created in consultation with the Australian research community. It makes it easier for researchers to discover, find information about, and request access to clinical trial data for secondary use. Meanwhile, the researchers who created and shared the data always maintain control over their data and determine with whom it is shared in line with community standards and funding requirements.

Health Data Australia aims to support research collaboration, inspire new research questions, make research data more discoverable, streamline data access and sharing and facilitate more efficient and effective research to improve health outcomes.

Visit Health Data Australia. The following resources will help you use the platform:

  • a user guide
  • FAQs on using the platform, sharing, contributing and accessing clinical trials data, governance, and potential risks
  • a showcase of the platform by Dr Rhys Williams, Manager, Expertise and Research Data Specialist (Health and Medical), ARDC.

Setting Up Clinical Trials for Data Sharing

The sharing and reuse of health research data should be planned from the trial’s inception.  Considerations and requirements for sharing clinical trial data include: 

  • identifying funding bodies’ data sharing expectations
  • outlining in the study protocol what data will be shared
  • how the data will be made available. 

It is crucial to incorporate consent for data reuse in participant forms and acknowledge data sharing requirements in the data management plan, ethics application and third-party agreements. The trial should be marked as “available for data sharing” in the clinical trial registry.

The following resources will help lay the groundwork for data sharing:

Metadata in Clinical Trials

Health research and clinical trials generate large volumes of valuable data, some of which contains sensitive information that must be handled and stored safely by the data custodian. 

Alongside the clinical data, research also generates metadata. Metadata describes the characteristics of a dataset and allows other researchers to learn about the data while protecting confidential information, preserving privacy and maintaining security.

Making metadata available through Health Data Australia provides researchers with a centralised, streamlined way to find and request access to data sets. While the metadata is publicly visible, the data custodian retains control over their data and determines with whom it is shared. 

By facilitating data sharing through metadata, the longevity and impact of the original research can be extended, and the data can be reused to improve health outcomes for all Australians.

Use a national metadata standard developed by the ARDC for clinical trials data discovery.

Further Resources

  • To learn more about HeSANDA, its value, how it works and the HeSANDA network, read this flyer.
  • Watch the recording of “Advancing Health Research Through Data Sharing”, a national symposium on health research data sharing hosted by Health Translation SA in October 2023.

Also explore Health Translation Queensland’s Clinical Trials Hub, which offers practical resources and tools – including Health Data Australia – for clinical trial teams to effectively plan, manage and track the progress of their clinical trials.