Collaborating with Karolinska Institutet for Advanced Real-World Data Analysis

A collaborative initiative with Karolinska Institutet and Janssen for research and development for a program in Real World Evidence launched in 2015. It aimed to improve health outcomes for patients by accelerating research and real-world data generation and analysis, increase transparency and information sharing, and enhance the understanding and utilization of real world data.

In 2018, Janssen and Karolinska Institutet, one of the world’s foremost medical universities and Sweden’s single-largest center for medical research, celebrated three years of collaboration in what has emerged as one of the largest real-world evidence (RWE) initiatives in the Janssen network. Sweden and Karolinska Institutet are both at the global forefront of RWE, thanks to a national healthcare system, rich registries, advanced biostatics capabilities and research tradition.

The Swedish registries contain uniquely comprehensive and connected information, including family structure, social insurance, income, education, crime, and more. Karolinska Institutet’s experience and publication history from these registries provides potential for important insights.

The collaboration has focused on the follow-up and effects of disease and treatment, using routine data from health care ("Real World Data"), and how they relate to effects in clinical trials, all while social and economic factors are evaluated.

Five Research Teams in Five Areas

Since launch in 2015, a number of research posts have been created for RWE. The overall intent is to study the relationship between randomized trial and observational data from clinical practice, to increase understanding of how these can be comparable, and how observational data can be used as an adjunct to clinical trial data.

A joint group of researchers have conducted in-depth studies that aim to unveil new data about treatment resistant depression, B-cell malignancies, prostate cancer and psoriasis while pursuing Real World Evidence and its effects on patients and society.

“From a research perspective, this is not only about delivering results to be used in scientific publications. It is about delivering something that falls under actionable research. This means that knowledge and results generated can and will be used to improve clinical decision making for new treatments and health outcomes,” says Richard Cowburn, Project Manager, and responsible for corporate collaboration at Karolinska Institutet.

Future Challenges and Shift in Focus

For the final year of the initial agreement, teams are beginning plans for expanding the types of real world evidence included, potentially extending the collaboration, and publishing several additional posters and manuscripts to describe outcomes of the research.

“My wish is that this collaboration in the future will evolve from primarily registry-based real-world evidence to additional promising areas such as input into early discoveries and identification of potential biomarkers and new targets,” says Janssen’s Christoph Glaetzer, Vice President, Global Market Access. “This has initially not been on our radar and indicates that there are many more opportunities around real world evidence. With initiatives like this one with the KI, we will expand our efforts to tap into this potential to address areas of high unmet need for patients worldwide.”

Facts and Figures About the Partnership

• The collaboration started in May 2015, with active research underway in 2016.
• The five focus areas for research are: Methodology, Depression, B-cell malignancies, Prostate cancer and Psoriasis.
• There are nearly 60 employees from Janssen and Karolinska Institutet involved in the collaborative research.
• Twenty-one (21) total posters and manuscripts have been issued.
• Approximately 10 registries, covering more than 200 million patient lives, have been used in the research.