An Innovative Approach to Event Assessment Goes Live


The assessment of adverse events is one of the key challenges in pharmacovigilance. Bayer now realized an innovative approach to increase the efficiency in this process: The software Cognium® determines the key properties “listedness“ and “company causality“ for reported product-event combinations. In a proof-of-concept it could be shown that the self-learning system yielded an initial assessment quality of about 90 % compared with human experts. Now, the solution was implemented by Cognium® creator Lenolution and system integration partner Syncwork.

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The processing of adverse events is one of the main challenges for drug producers in pharmacovigilance. Increasing case numbers, ever-changing regulatory reporting requirements, as well as new case sources, such as social media, consume a growing amount of resources in pharmacovigilance departments.

A new approach to make case processing more efficient was now taken at Bayer AG by employing the innovative software Cognium®. The system calculates an essential information in the analysis of adverse event reports. Its core features compute assessments for two important aspects of each product-event combination:

  • Listedness: Is this combination already listed, i.e., known to the producer?
  • Causality: Can a relation between the product and the event be derived from the available reported data?

The causality assessments are based on Bradford Hill criteria (strength, consistency, specificity, temporality, biological gradient, plausibility, coherence, experiment, analogy). As result, Cognium® provides its assessment including probability values, such as “with 80 % certainty the adverse event is caused by the product“. Since the system adjusts the algorithm parameter settings based on experience, it improves the results with growing historic data (self-learning component).

Cognium® was developed by the Berlin-based Lenolution GmbH and implemented at Bayer with system integration partner Syncwork AG. After a test period of several months Magnus Lerch, CEO of Lenolution, stated: “We could even improve on the quality that was already reached in the proof-of- concept. The assessments are consistent with those of human experts in about 90 %. We expect that this percentage will even get better with the time when the software is fully exploiting its learning features.“

Bayer project manager Klaus Ristau: “The additional calculation of this information is of particular interest to us, since it will focus our quality measures where the need is most important. Now, in a first phase we will test the solution in a productive setting by integrating Cognium® in our quality management process. However, we see a tremendous potential for improving the efficiency in our case assessment process.“

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