Medaffcon unlocks new research opportunities with Swedish real-world health data

Research based on Finnish and Swedish real-world health data can be generalised also to other settings and populations, says Dr. Johanna Simin, real-world epidemiologist at Medaffcon.

Swedish real-world health data, a recent addition to the in-house capabilities of Medaffcon, offer unique possibilities for measuring disease burdens and determinants, the effects of different exposures, and the outcomes of various health conditions in a population of almost 10.5 million people.

The data are distributed between several owners, across dozens of national and regional databases, researcher-generated databases, some 400 biobanks and 100 disease-specific quality registers.

“Sweden has a tremendous amount of data at the population level with high coverage and concordance – sometimes up to 100 per cent. In theory, everyone is included,” tells Dr. Johanna Simin, real-world epidemiologist at Medaffcon in Stockholm. “And the data can be linked with each other thanks to the unique Swedish identity number.”

“Sweden has a tremendous amount of data at the population level with high coverage and concordance – sometimes up to 100 per cent.”

Dr. Simin says a well-designed study based on real-world data can provide valid and valuable insights into the disease burden, patient groups most likely to benefit from a novel therapy, and risk factors and outcomes.

What should be recognised more widely, she adds, is that these data sources offer multi-component information that is not limited to a group of highly selected individuals, as is generally the case in randomised controlled trials.

“Findings from Finnish or Swedish real-world health data-based research can be extrapolated to other relatively similar populations, such as Germany. As long as the applied methods are solid and well designed, we can achieve good internal validity and, as a result, external validity, which allows us to generalise the results to other settings and populations,” she explains.

Insights into rare diseases

The Swedish quality registers are regarded as a national treasure, not dissimilarly to hospital districts’ data lakes in Finland. Dr. Simin describes the registers as an excellent asset for advancing precision medicine and preventive therapies that allows researchers to delve deep into different aspects of health conditions – be it their treatments, outcomes or burdens – and identify new unmet needs.

The Swedish quality registers are regarded as a national treasure, not dissimilarly to hospital districts’ data lakes in Finland.

For example, the breast cancer register (NKBC) encompasses 97 per cent of cases in the National Cancer Register. Dr. Simin tells that the register covers on average 54 per cent of complete pathology reports, which include such details as cancer grade, hormone receptor status and the expression of relevant proteins HER2 and Ki67.

“This is good considering the register’s overall coverage and annual number of breast cancer cases. In some regions, you can examine pre-operative oncological treatment with a 100-per-cent completeness level,” she says.

Dr. Simin has also utilised data registers to investigate the effect of menopausal hormones on various cancer types, including oesophageal cancer.

“Among virtually all of the nearly 300,000 menopausal hormone users in Sweden, we had 86 women diagnosed with oesophageal cancer between 2005 and 2012,” she tells. “This demonstrates that when you have the necessary volume – of both people and data – you can also take on diseases that are very rare, be it in general or in a particular population group.”

“When you have the necessary volume – of both people and data – you can also take on diseases that are very rare, be it in general or in a particular population group.”

The permit processes tend to be smooth, too. The Swedish Ethical Review Authority typically assesses the application within 60 days, allowing the permit to be validated fairly quickly by the data owner.

“I remember receiving approval in as little as a couple of weeks. And the process is always supportive, with constant dialogue to minimise misunderstandings and facilitate the data retrieval,” she recounts, drawing on her decade of experience in using real-world health data as a pharmacoepidemiologist at Karolinska Institutet in Stockholm.

Sweden to hold on to leading status

The Swedish Research Council recently published a report calling for further investments in research that support medical and pharmaceutical innovation and greater utilisation of the abundance of real-world health data, including by means of virtual control arms. The Swedish Government has already responded, allocating long-term funding for developing and maintaining the quality registers.

This signals the country’s intent to remain a leader in innovative and translational research, views Dr. Simin.

“There’s clearly a genuine desire to stay ahead and share data for research and innovation purposes – and not only a desire, but a genuine effort. There’s a clear plan for how to accomplish this,” she comments. “This sends a signal to researchers not only in the academia, but also in the life sciences sector that it’s time to ramp up investment in research.”