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.
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 OLeary, Bassam
Bafadhal, Mustafa Dungarwalla, Harshvinder Bhullar, Louise Pinder, James
Philpott).
Chapter 4 IQVIA Medical Research Data (IMRD) (Caroline
OLeary).
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, Systčme 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 sanitą della Toscana (ARS) Database (Rosa Gini).-Chapter
12 Caserta Record Linkage Database (Gianluca Trifirņ, 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 Maciį,
Julio Bonis, Consuelo Huerta, Elisa Martķn-Merino, Arturo Įlvarez, Verónica
Bryant and Dolores Montero on behalf of BIFAP Team).
Chapter 15 The
Information System for Research in Primary Care (SIDIAP) (Talita
Duarte-Salles, Marķa Aragón, Bonaventura Bolķbar).- 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 lassurance 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).
Tania Schink is the Head of the Drug Safety Unit at the Leibniz Institute for Prevention Research and Epidemiology BIPS. She holds a Masters (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.
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