Unlocking the Potential of Clinical Trials Data with Health Data Australia

Clinical trial data can be used beyond the original study it was intended for, helping to answer new research questions, validate existing research, and advance learning and education. However, the re-use of clinical trial data can be hindered by difficulty finding and accessing relevant data. The ARDC’s Health Data Australia catalogue makes searching for this secondary data easy and quick.

The ARDC hosted a webinar to raise awareness about Health Data Australia and show the value of using secondary clinical trials data. The June 2024 webinar ‘Unlock the potential of secondary data from clinical trials with Health Data Australia’ had over 160 registrants from universities and research institutes across Australia.

Health Data Australia: A Catalogue of Accessible Secondary Data 

Health Data Australia is an online national catalogue of Australian clinical trials data that allows researchers to discover and request data for their research. Since its 2023 launch, over 72 health research organisations nationwide have contributed to more than 190 datasets. Alongside each dataset, the catalogue provides information about the data and who created it. Users can browse the catalogue and access data by submitting a data sharing request.

“The Health Data Australia platform is a great place to find Australian clinical trials data registered on the ANZCTR [Australian and New Zealand Clinical Trials Registry] or Clinical Trials.gov”, said Dr Kylie Hunter, associate convenor of the Cochrane Methods Prospective Meta-analysis group, who uses Health Data Australia in her research.

The Benefits and Uses of Secondary Data

Increasing the accessibility and re-use of existing data not only enhances its value, but also provides a richer pool of data and evidence to draw on to support research and decision-making. It also encourages enhanced collaboration.

Dr Kristan Kang, ARDC Program Manager, urges researchers to consider this benefit. “If I share my data, what kinds of collaborations could I undertake with this, what kinds of additional things could I be involved with just by collaborating with people outside my group?”

Secondary Data in Action

There are 4 key types of research using secondary clinical trials data: 

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).

The webinar showcased examples of how researchers use secondary clinical trial data across these 4 types of secondary research. 

Dr Sol Libesman from the NHMRC Clinical Trials Centre used evidence synthesis to investigate umbilical cord clamping in preterm children. During the 20th century, routine practice involved immediately clamping the cord after birth. However, traditional systematic reviews and single trials could not conclusively answer whether this was the most effective strategy. 

Using individual participant data meta-analysis from 54 trials around the world, Dr Libesman and his team found that waiting to clamp the cord after birth significantly reduced mortality compared to immediate clamping. 

“Our network meta-analysis showed that a long deferral of cord clamping reduced mortality risk by about 70%, which is a huge effect,” said Dr Libesman. “The takeaway is that [the conclusions] were all facilitated by data sharing.”

Dr Angelina Tjokrowidjaja, a medical oncologist and CTC Future Leader Research Fellow, collated data from 4 primary studies looking at an effective new treatment for women with relapsed ovarian cancer following chemotherapy. “The research question that remained unanswered was how do we best monitor women to detect cancer growth on this new treatment?” said Dr Tjokrowidjaja. 

Traditional methods monitor a tumour marker in the blood, CA-125, to measure cancer response and progression. A rise in these markers prompts the need for CT or PET imaging to gain further information. “Using secondary analyses, we found that monitoring through CA-125 alone is not a reliable detection of cancer growth,” she said. 

Their research found that CT scans could detect cancer progression in some patients who did not show a rise in the tumour marker in the blood. As a result, they recommend routine follow-ups with CA-125 monitoring and periodic CT scans; a recommendation that now informs clinical practice.

“High-quality data can address new questions… so there is this opportunity to maximise the value of trial data through secondary analysis,” said Dr Tjokrowidjaja.

Dr Anna Lene Seidler, co-convenor of the Cochrane Methods Prospective Meta-analysis group, agrees. “We’re able to answer new research questions without having to go back and collect data,” she said.

Dr Kristy Robledo, CTC Future Leader Fellow in biostatistics, then showed how existing data sets can be leveraged for education, training and learning purposes. She discussed the importance of using secondary data in methodological research, particularly when developing new methods for data analysis.

“Datasets provide raw material that is necessary for new methods, particularly for machine learning algorithms. These methods need access to varied, comprehensive, large and diverse datasets to train and validate their models to make sure they work across a lot of different scenarios.”

“Using simulated data is useful, but real case studies are so useful – you just can’t beat real data,” said Dr Robledo.

Unlock Secondary Clinical Trials Data 

The webinar highlighted the benefits of re-using existing clinical trials data. “We wanted to show that there are many different kinds of research that can be done with existing clinical trials data,” said Dr Kang. “There is a way to open up new opportunities for collaboration to increase impact.”

Alongside the webinar, a complementary online practical guide has also been released, providing a theoretical framework for the 4 types of data re-use scenarios. The practical guide was extracted from research papers, and consultation with stakeholders and the research community, serving as a useful resource for secondary data users. 

The ARDC created the Health Data Australia platform to help researchers get better access to data for their research, allowing them to unlock the benefits of secondary clinical trials data. Health Data Australia is part of the ARDC’s People Research Data Commons, which is establishing national-scale research infrastructure for health and medical research. 

Health Data Australia was co-designed by the Health Studies Australian National Data Asset (HeSANDA) Clinical Trials project, which is a partnership of 9 nodes, representing 72 research organisations across Australia, covering most of Australia’s states, territories, and health researchers. The 9 nodes help researchers and data custodians contribute metadata to the Health Data Australia catalogue and manage data sharing requests.

We’d like to hear more about your research and how we can improve Health Data Australia to make it more useful for you. Provide your feedback by 23 September 2024 completing our online survey.

Watch the webinar recording

Find secondary clinical trial data via Health Data Australia, or read the secondary user practical guide.

The ARDC is enabled by the National Collaborative Research Infrastructure Strategy (NCRIS) to support national digital research infrastructure for Australian researchers.