Download the research on “Utilization of anonymization techniques to create an external control arm for clinical trial data”

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We designed a study together with our partners Bayer and MedEngine to compare the use of anonymized and pseudonymized Real-World Data (RWD) in creating external control arms (ECAs) for single-arm randomized controlled trials (RCTs). ECAs serve as control groups in trials with only new treatment recipients.


The study, published in BMC Medical Research Methodology, showed that one could draw the same conclusions from anonymized data as from traditional pseudonymized, individual-level research data.


Anonymized data is GDPR-free and therefore can be utilized in many use cases enabling a safe way to share sensitive data.

This is a significant achievement. In our study, we could draw the same conclusions from anonymized data as from traditional pseudonymized, individual-level research data.

Jussi Leinonen,

Strategic Project Lead

Bayer