From unified origins to the forefront of pharmacoepidemiology and Real-World Evidence research
In the aftermath of the fall of the Berlin wall and German reunification, many of the German Democratic Republic academic departments folded or were amalgamated into ‘unified’ organisations. At this time, epidemiologists Professor Siegfried Boethig and Professor Lothar A J. Heinemann established the private entity ‘Center for Epidemiology and Health Research’ (ZEG Berlin), originating from their epidemiological department at the GDR Academy of Science.
Boethig and Heinemann started their careers in the 1960s at the epidemiological study center of Humboldt University Berlin (Charite Hospital). Collaborating on various cross-sectional population studies, they focused primarily on cardiovascular health. Over the next four decades, Boethig and Heinemann developed methodological standards for the conduct of pharmacoepidemiological studies – simultanously with the Slone Epidemiology Center at Boston University and McGill University. They also oversaw multicenter prevention projects targeting chronic non-communicable disease in school children (CANON and CINDI). As key members of the Academy of Science, they participated in the international studies, MONICA, WHO OC, WHO children and the global INTERSALT project. Boethig was appointed Head of the Cardiovascular Disease Unit of the WHO, Geneva. The epidemiological department of the Academy of Science operated as the German WHO Reference Centre for non-communicable diseases.
After the foundation of ZEG Berlin in 1990, Boethig and Heinemann initially managed many ongoing preventative population health studies previously run through the Academy of Science. Increasingly, they collaborated with the pharmaceutical industry, making ZEG Berlin a leader in large-scale, post-market cohort studies.
EURAS-OC study a turning point for ‘Third Generation Pill Crisis’ and ZEG Berlin
The ‘Third Generation Pill Crisis’ in Europe in the late 1990s was a turning point for ZEG Berlin. Collaborating with stakeholders, our statisticians and epidemiologists developed the EURAS study design. The prospective patient-reported outcomes cohort methodology was able to accurately assess the real-use risk of very rare adverse outcomes in a population of healthy individuals. The EURAS-OC study was critical in resolving safety concerns regarding combined oral contraceptives. The study design has been used effectively in numerous Post Authorization Safety Studies (PASS) and risk management studies since.
ZEG Berlin is at the forefront of pharmacoepidemiology research, specializing in the early detection and quantification of safety risks associated with the use of therapeutic, preventative or diagnostic drugs. In 2021, we bridged our classical research division with a new division for Real-World Evidence (RWE) and Safety Data Analytics. Areas of focus include Epidemiology, Health Economics and Outcomes Research (HEOR), and Safety, as well as a broad range of therapy areas. The integrity of ZEG Berlin’s long history in developing and implementing Post-Authorisation Studies using primary data will be combined with new access to Real-World Data (RWD) and methodology essential to meeting the constantly changing requirements of the medical community and of regulatory authorities. ZEG Berlin, part of the Cerner Enviza ecosystem, and our network of research offices assist in conducting studies across Europe, Asia-Pacific, the Americas, and the Middle East.