Experts say Australia is on the cusp of turning real-world health data into a clinical and policy game-changer – if it can break down silos, protect privacy, and connect the dots.
The real-world data space is increasingly recognising the value of qualitative data that captures patient-specific values and experiences.
It can help researchers and policy makers develop better ways for disease prevention and cure, and enhance quality of care, but to harness its value, there is a need for stronger infrastructure, governance, and interoperability frameworks.
A recent New England Journal of Medicine Perspective by former FDA Commissioner Scott Gottlieb and colleagues highlights the growing significance of real-world data (RWD) in clinical research, regulatory decisions, and health system improvement.
Despite its promise, major barriers, including fragmented data systems, variable quality, and limited linkage between real-world evidence (RWE) and clinical decision-making, restrict its full potential, they say.
Sallie Pearson, Professor of Health Systems and director of NHMRC Centre of Research Excellence in Medicines Intelligence at UNSW said RWD had the potential to be a reliable complement to randomised controlled trials.
“The power comes from understanding the evidence generated in clinical trials, which is really the gold standard for establishing treatment efficacy; and then complementing that with RWD, which accurately reflects the way people interact with the healthcare system in everyday life. It is a powerful way of using both types of evidence to inform policy and practice,” she said.
“We can leverage what clinical trials have taught us about transparency and reproducibility by developing publicly available protocols, detailing study designs and appropriate statistical analyses. This will really enhance the credibility and legitimacy of RWD and RWE in the context of clinical and policy decision making.”
In Australia, health data is collected across the Commonwealth and also within the states and territories. This has made bringing data together complex and obtaining data challenging and time-consuming across jurisdictional boundaries.
“We need to prioritize more streamlined and transparent ethics and governance processes for data access, build good guardrails to protect Australians’ privacy, and create a one-stop-shop with clarity in governance to accelerate RWE development for health technology assessments in the country,” said Professor Pearson.
Notably, two good assets – the Australian Institute of Health and Welfare (AIHW) and the Australian Bureau of Statistics (ABS) – are now combining data, though most of it is claim data, payment data or survey data, not Electronic Health Records (EHR) or detailed patient records. Another asset, Lumos, links general practice data with hospital and other data from NSW Health.
The Australian Research Data Commons (ARDC) is working on leveraging more of the state-based EHR; and the Australian Cancer Atlas is an online, interactive platform showing patterns of cancer burden across the country.
“The dots are being joined, but it will take time to join them entirely as it’s the people, the partnerships and the science that needs to be linked up as well,” said Professor Pearson.
The federal government is investing in progressing the National One Stop Shop project, which will streamline health and medical research through a single, national approvals and data system.
“This will make it easier for patients, researchers and sponsors to find, conduct and participate in clinical trials and research in Australia,” according to a Department of Health, Disability and Ageing (DoHDA) spokesperson.
The US, Canada and Europe are developing frameworks, tools and methodological approaches demonstrating the value of RWD for public benefit. Experts say these can be leveraged or easily adapted to Australian context.
Distinguished Professor Kerrie Mengersen, founding director of the Centre for Data Science at Queensland University of Technology said clinical registries were “a great example of where we are starting to get it right in gathering and storing high quality data”.
“However, in scaling them up, we really need to continue this debate and discussion around the trade-off between provision of information and the privacy of people,” she said.
“Australia is in a good position as we have some legal and ethical rules around data governance and management, though not as stringent as in Europe.”
The government’s recent Productivity Commission report has sparked a review of data privacy and sharing practices, particularly focusing on how to balance data availability for public benefit with individual privacy protections.
“It’s really important for individuals to be data literate,” Professor Mengersen said.
“They should be aware of their own health data, how and where that data is being stored and used, how to interpret the health information as data, and having agency over their own health decisions based on those data.”
The Digital Health Blueprint and Action Plan 2023–2033 roadmap outlines the government’s vision for an integrated health system, where digital and data capabilities for Australians are accessible, affordable, collaborative and person centred.
Neena Bhandari is a Sydney-based freelance journalist.
