A guide to secondary data sharing in clinical trials

Clinical trials produce extensive and valuable data on participants, including their health status, treatment response and interactions with the interventions being studied.

Sharing of clinical trial data and outputs has great potential to enhance research and scientific knowledge, advance patient care and improve public health. By not sharing opportunities to generate additional knowledge participant contributions are not fully maximised.

Benefits of data sharing

Clinical trial data sharing has significant benefits to a number of stakeholders.

Benefits to researchers

• Enables the creation of richer, more comprehensive data sets that spark new research questions and hypotheses.

• Increases citations of the original work, enhancing the authors' academic impact and research reputation.
• Supports career growth and funding as sharing data aligns with funding requirements, strengthening credibility and improving grant prospects.

 Benefits to organisations

• Increases institutional visibility by enhancing the organisation's reputation through greater exposure of their research.
• Promotes collaboration and networking by fostering partnerships with other institutions, researchers, and industry leaders.
• Attracts funding and grants and demonstrates transparency and aligns with funding agency priorities, boosting future funding opportunities.
• Advances scientific leadership – positions the organisation as a leader in open science, driving innovation and influence in the field.

Benefits to the community

• Reduces unnecessary duplication of research effort, allowing for a more streamlined research process. This not only accelerates the development of new treatments but also ensures that resources are used more efficiently, ultimately benefitting patients.
• Minimises participant exposure to avoidable harms. When researchers have access to previous trial data, they can identify potential safety concerns, adverse effects, or inefficacies early in the research process. This can prevent participants in future trials from being exposed to interventions that are unlikely to be beneficial or may pose unnecessary risks.

What data can I share?

Responsibilities of researchers for the sharing and re-use of data are outlined in the National Statement on Ethical Conduct in Human Research (2025) and the Management of Data and Information in Research: A guide supporting the Australian Code for the Responsible Conduct of Research.

When thinking about what data you want to share consider the following:

• What data will be shared – individual participant data or an aggregated data set?

• Will other outputs, such as the trial protocol and data dictionary, be shared?
• When will the data be available for sharing and for how long?
• Whether you will include your trial in a data sharing catalogue (e.g. Health Data Australia).

Plan to share your data at the start of your trial

In the application process you should consider whether you will share data and information generated from your clinical trial.

If you decide to share, there are a number of documents in the application process where details of data sharing need to be documented. This relates to setting up your study in such a way that your study data and outputs can be shared openly and are made accessible for secondary re-use.

Study protocol

Study protocols must explain how participant data will be managed in terms of data storage and security for secondary re-use purposes. The protocol should document the following:

• where will the data be stored (e.g. REDCap)

• how will security of and access to the data be determined

• length of time the data will be stored
• when and how data should be destroyed
• will the data for future access be re-identifiable or not
• will the data be individual participant data or aggregated
• who will approve requests for access to the data.

Human research ethics application

If required to complete the Human Research Ethics Application (HREA) by the approving Human Research Ethics Committee (HREC) the section on ‘data and privacy activities with your data’ will need to be completed to document intent for the future use of data for secondary research purposes. These questions ask to ‘describe any foreseeable future activities for which information/data collected and/or used in the project may be made available’ and to ‘describe any ethical considerations to the planned or possible future use of information/data’.

Site specific assessment

Research involving hospitals will have to undertake a site-specific assessment (SSA). In the SSA application the use of the data for secondary purposes will need to be documented again.

Patient information and consent form

In your participant information sheet you will need to include a section informing participants how their data may be shared in the future. In the consent form there should be a section to allow participants to decide whether or not they want to consent to their information being stored and shared for future research. CT:IQ have developed an InFORMed project template to support a participant-centred, simplified national patient information and consent form. This template provides an example of how to document the sharing and re-use of data for future research studies.

Clinical trial registry

All clinical trials have to be registered in a national registry. Within Australia, trials are registered on either ANZCTR or Clinicaltrials.gov. There are specific sections in the application that relate to secondary re-use of data. The data sharing statement describes whether and under what conditions, individual participant data from a clinical trials will be made available for research purposes.

Health Data Australia

Health Studies Australia National Data Asset (HeSANDA) is a national program of the Australian Research Data Commons (ARDC) and is supported by the National Collaborative Research Infrastructure Strategy (NCRIS).

The program aims to build national infrastructure required to support researchers to access, share and re-use data from health studies, in a way that will bring value to the research community, increase the efficiency of research and provide benefits for the health of Australia’s population.

The research community across Australia worked together through the HeSANDA program from 2021 to 2023 to develop Health Data Australia (HDA), a national catalogue designed to facilitate access, sharing and re-use of health research data.

Health and medical researchers can use the platform to:

• register descriptions of their data for discoverability by others
• discover and request access to data.

The infrastructure includes a federated network of local nodes. These nodes work with their organisations to collate metadata about clinical trials which are then discoverable in both the local node’s catalogue and in Health Data Australia. Importantly, the researchers who created the data always maintain control over their data and determine with whom it is shared.

The network consists of the following 9 nodes:

• HeSANDA Queensland Node
• Melbourne Academic Centre for Health (MACH) Clinical Trials Consortium Node
• Mental Health Node
• Monash and Partners Node 
• National Cancer Cooperative Trials Group Node – node email
• Northern Australia Node
• Sydney Node (Sydney Health Partners and NHMRC Clinical Trials Centre Node)
• South Australia Node
• Western Australia Node

If you are keen to register a description of your clinical trials in order for it to be discoverable in Health Data Australia, contact your local node today!