The rigorous code of conduct set by ENCePP is ZEG Berlin’s standard bearer
All studies by ZEG Berlin adhere to the code of conduct set by ENCePP, the European Network of Centres for Pharmacoepidemiology and Pharmacovigilance. ENCePP’s aim is to strengthen monitoring of the benefit-risk balance of medicinal products in Europe. It achieves this by facilitating high quality, independent, post-authorization studies and developing and maintaining methodological standards and governance principles in research. ZEG Berlin was invited to be a founding partner of ENCePP by the European Medicines Agency. All of ZEG Berlin’s eligible studies have been awarded the ENCePP seal.
Patient data pinpoints the frequency of known and rare adverse events
Post-authorization safety studies (PASS) investigate the frequency of already known adverse events and possible rare adverse events in a patient population that is typical of real-life users. In PASS, the patient is prescribed the drug prior to study entry and according to the therapeutic indication, not protocol. The decision about prescriptions and whether to include the patient in the study are clearly separated. Often the study population includes patients who would otherwise be excluded from clinical trials (e.g. secondary to chronic illness).
The ZEG Berlin European Active Surveillance/International Active Surveillance (EURAS/INAS) study design has been used extensively in PASS since 2000. By asking participants directly about their experiences with the study medication, we can gather data highly sensitive to the outcome of interest. All outcomes of interest are then validated by the treating physician to ensure that data is robust and specific to your needs. We are also able to include questions at both baseline and follow-up to elucidate important co-variables not easily sourced from electronic databases and registry data (e.g. mood, pain, and breastfeeding).
The EURAS/INAS study design is internationally acknowledged as being scientifically and methodically robust and effective in risk assessment in the post-marketing environment. Scott Monroe, Division Director of the FDA, came to the conclusion that: “The EURAS study could be considered a model study for future post-marketing studies”. In the context of the assessment of Venous Thromboembolic (VTE) risk, comparing different combined oral contraceptives (COCs), the FDA has stated: “The EURAS study is the most rigorously designed prospective cohort study published to date comparing the risk of VTE between different COCs.”
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