Databases for Pharmacoepidemiological Research

This book allows readers to gain an in-depth understanding of the role of real-world data in pharmacoepidemiology, and highlights the strengths and limitations of the respective databases with regard to pharmacoepidemiological research.

Over the past decade, the increasing use of real-world data in pharmacoepidemiological research has been accompanied by a growing recognition of the value of real-world evidence in clinical and regulatory decision-making. Electronic healthcare databases allow analyses of drug and vaccine utilization in routine care after approval, as well as investigations of their comparative effectiveness and safety. They are especially useful for the identification of rare risks and rare drug exposures over long periods of time, and as such sustainably extend the basis for drug safety research.

 This book provides an introduction to the role of real-world data in pharmacoepidemiological research and the main developments in the last 15years. It also offers a comprehensive overview of the general classification characteristics of databases, together with their strengths and limitations, and a detailed description of 21 individual databases, written by professionals who work with or maintain them. 

• Pharmacoepidemiology
• Databases
• Secondary data
• Pharmacovigilance
• Clinical trials
• Drug safety
• Drug secondary data
• Claims database
• Electronic healthcare database
• Electronic health records
• Effectiveness
• Drug and Vaccine utilization
• Drug risk
• Post-authorisation/authorization safety studies
• Post-marketing surveillance
• Real-world evidence

• Erasmus MC, Rotterdam, The Netherlands

  Miriam Sturkenboom

• Leibniz Institute for Prevention Research, Bremen, Germany

  Tania Schink

Tania Schink is the Head of the Drug Safety Unit at the Leibniz Institute for Prevention Research and Epidemiology – BIPS. She holds a Master’s (“Diplom”) in Statistics from the Ludwig-Maximilians-Universität in Munich, a PhD in Medical Sciences from the Charité (Humboldt University) in Berlin and a Master of Public Health from Harvard School of Public Health in Boston. She has more than 10 years of experience in pharmacoepidemiology, working on EU-funded multi-database studies, post authorization safety studies, and research projects regarding the use and safety of drugs in vulnerable populations such as the elderly and pregnant women.

Miriam Sturkenboom is a pharmacoepidemiologist from the University Medical Center Utrecht and Professor of Real World Evidence. She worked for 20 years at the department of Medical Informatics, Erasmus MC, as a Professor of Observational Data Analysis. She is a past president of the International Society for Pharmacoepidemiology, she currently serves as an advising expert to the EMA, WHO, the Task Force for Global Health, the Brighton Collaboration and CEPI. Her research interests focus on knowledge discovery from data collected in routine healthcare to improve evidence on drug and vaccine safety, particularly in vulnerable populations (children, pregnant women and the elderly).  She has pioneered and implemented many collaborative distributed data network studies on European and global vaccine and drug safety. She has supervised more than 50 PhD students and published more than 400 peer-reviewed papers in the areas of pharmacovigilance, pharmacoepidemiology and medical informatics. 

Policies and ethics