Clinical trials and data linkage
Australia has world-class health data, but we’re not using it to its full potential, especially to boost medical breakthroughs through clinical trials. By linking existing data, we can uncover new insights, save time and effort. Combining administrative data has great potential to enhance findings and reduce some of the burden of data gathering.
Benefits of using linked data
Linking administrative data to clinical trial data can significantly enhance your research. It provides valuable insights, reduces the effort needed to collect data, and can improve the quality of findings. Below are some of the key benefits of using linked, routinely collected data in clinical trials:
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Reduced costs
Time and effort saved
Increased validity and reliability
Reduced reporting and recall bias
Real world data
Access data that is already routinely collected. The cost of accessing this data is substantially less than the cost of prospective data collection.
Linking pre-existing data from whole populations and/or across decades can be done more efficiently than prospective data collection.
Linkage with whole of population data allows you to describe the representativeness of your trial population and the generalisability of its outcomes.
Augmenting trial data with linked administrative data can minimise missing information, improve data quality through multiple sources, and reduce reliance on patient memory.
Provide insight on the effects of interventions in the general population, including those who don’t fit the strict eligibility criteria of a clinical trial.
Potential ways to use linked data
Potential ways to use linked data
Measure healthcare use before/after intervention
Total feasibility assessment
Innovative clincial trial design
Pre-trial research on disease epidemiology, measure disease burden and key determinants, and identify eligible individuals or communities using linked data
Utilise longitudinal administrative data to assess healthcare and pharmaceutical use pre- and post-intervention.
Linkage with administrative health data can help assess feasibility before initiating a trial, reducing unnecessary research efforts
Facilitate more efficient trial approaches, such as cluster, adaptive, and platform trials, enabling faster translation of findings.
Measurement of primary and secondary endpoints
Identify eligible individuals or communities
Surveillance and monitoring
Health economic analysis
Whole-population data enables tracking of primary endpoints such as death, or secondary endpoints like hospital readmissions.
Support site selection, identify at-risk populations, and determine the number of eligible individuals meeting trial criteria within a given jurisdiction.
Assess product or intervention utilisation and monitor safety and report adverse drug events.
Certain data collections include payment and cost information, supporting robust health economic evaluations.
Long term follow-up
Representativeness of trial participants
Pre-recruitment insights and monitoring
Leverage linked data for extended follow-up, supplement missing follow-up data retrospectively, and assess long-term health outcomes and healthcare utilisation using the longitudinal structure of administrative datasets.
Linked data can be used to assess whether participants are representative of the broader population and examine representation of rural and remote populations, First Nations Australians, or individuals from lower socioeconomic backgrounds.
Linked data collected before recruitment can be used to establish the journey of participants before enrolment, such as pre-recruitment hospitalisation as a measure of the trajectory to care.
An industry-first offering that lowers the barriers to accessing linked data – improving health services and patient outcomes across Australia.
The Population Health Research Network (PHRN) is committed to supporting clinical trialists in using linked real-world data. In 2023, the PHRN received funding to develop a national integrated gateway that will help clinical trial researchers discover, link, access, and learn about linked data more efficiently. This initiative—Trial Link—aims to:
Using linked data in clinical trials: how the PHRN can support you
Discover
Data
Access
Guide
Learn
Project examples
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Harper C, Mafham M, Herrington W, et al. (2021). Comparison of the accuracy and completeness of records of serious vascular events in routinely collected data vs clinical trial–adjudicated direct follow-up data in the UK: secondary analysis of the ASCEND randomized clinical trial. https://dx.doi.org/10.1001/jamanetworkopen.2021.39748
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Hay AE, Leung YW, Pater JL, et al. (2018). Pilot study of the ability to probabilistically link clinical trial patients to administrative data and determine long-term outcomes https://doi.org/10.1177/1740774518815653