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 15 years.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.

Autorentext

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.

Inhalt
Part 1 : Databases for Phramacoepidemiological Research Chapter 1 Introduction (Miriam Sturkenboom)

Chapter 2 Overview of databases (Iris Pigeot, Maike Tahden, Dimitrios Zampatis, Douglas J. Watson, Ulla Forssen, Bianca Kollhorst)

Part 2 : Databases in Europe.-

Chapter 3 Clinical Practice Research Datalink (CPRD) (Melissa Myland, Caroline O'Leary, Bassam Bafadhal, Mustafa Dungarwalla, Harshvinder Bhullar, Louise Pinder, James Philpott)

Chapter 4 IQVIA Medical Research Data (IMRD) (Caroline O'Leary)

Chapter 5 The Health Service Executive Primary Care Reimbursement Services Database in Ireland (Ireland HSE-PCRS) (Sarah-Jo Sinnott) Chapter 6 Administrative Registers in Finland, Sweden, and Norway (Tuire Prami, Rosa Juuti, Ilona Iso-Mustajärvi)

Chapter 7 PHARMO Database Network (Ron Herings, Marina Bakker)

Chapter 8 German Pharmacoepidemiological Research Database (GePaRD) (Ulrike Haug, Tania Schink)

Chapter 9 Institute for Applied Health Research Berlin (InGef) Database (Frank Andersohn, Jochen Walker )

Chapter 10 National health insurance claims database in France, Système Nationale des Données de Santé (SNDS) and Health Data Hub (HDH) (Nicholas Moore, Patrick Blin, Régis Lassalle, Nicolas Thurin, Pauline Bosco-Levy, Cécile Droz)

Chapter 11 Agenzia regionale di sanità della Toscana (ARS) Database (Rosa Gini) Chapter 12 Caserta Record Linkage Database (Gianluca Trifirò, Valentina Ientile, Janet Sultana, Michele Tari)

Chapter 13 Pedianet Database (Anna Cantarutti)

Chapter 14 BIFAP Program: A data resource for Pharmacoepidemiological research in Spain (Miguel Gil, Miguel Angel Maciá, Julio Bonis, Consuelo Huerta, Elisa Martín-Merino, Arturo Álvarez, Verónica Bryant and Dolores Montero on behalf of BIFAP Team)

Chapter 15 The Information System for Research in Primary Care (SIDIAP) (Talita Duarte-Salles, María Aragón, Bonaventura Bolíbar)

Chapter 16 Estonian Health Insurance Fund (EHIF) Database (Sirly Lätt, Helis Puksand)

Chapter 17 Icelandic Medicines Registry (IMR) (Larus S. Gudmundsson, Olafur B. Einarsson, Magnus Johannsson)

Part 3 : Databases in North America.- Chapter 18 Régie de l'assurance maladie du Québec (RAMQ) databases (Machelle Wilchesky, Samy Suissa)

Chapter 19 Medicaid and Medicare (Dirk Enders, Tania Schink, Til Stürmer)

Chapter 20 Truven Health MarketScan Research Databases (MarketScan) (Anne M. Butler, Katelin B. Nickel, Robert A. Overman, M. Alan Brookhart)

Part 4 : Databases in Asia and Australia

Chapter 21 Australian Pharmaceutical Benefits Scheme (PBS) Dispensing Database (Emily A. Karanges, Melisa J. Litchfield, Leigh Mellish, Sallie-Anne Pearson)

Chapter 22 National Insurance Claims Database (NDB) (Daisuke Sato, Kazuhiko Ohe) Chapter 23 National Health Insurance (NHI) Database (K. Arnold Chan)