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.

Dieses Lehrbuch, ein wegweisender Klassiker, bietet in der 6. Auflage noch mehr Inhalte für Leser, die aktuelle Informationen zur Pharmakoepidemiologie benötigen. Die vorliegende Auflage wurde vollständig überarbeitet und aktualisiert. Sie bietet einen Überblick über sämtliche Facetten des Fachgebiets, aus Sicht von Lehre und Forschung, aus Sicht der Industrie und von Regulierungsbehörden. Datenquellen, Anwendungen und Methodiken werden verständlich erläutert.

This book trains the next generation of scientists representing different disciplines to leverage the data generated during routine patient care. It formulates a more complete lexicon of evidence-based recommendations and support shared, ethical decision making by doctors with their patients. Diagnostic and therapeutic technologies continue to evolve rapidly, and both individual practitioners and clinical teams face increasingly complex ethical decisions. Unfortunately, the current state of medical knowledge does not provide the guidance to make the majority of clinical decisions on the basis of evidence. The present research infrastructure is inefficient and frequently produces unreliable results that cannot be replicated. Even randomized controlled trials (RCTs), the traditional gold standards of the research reliability hierarchy, are not without limitations. They can be costly, labor intensive, and slow, and can return results that are seldom generalizable to every patient population. Furthermore, many pertinent but unresolved clinical and medical systems issues do not seem to have attracted the interest of the research enterprise, which has come to focus instead on cellular and molecular investigations and single-agent (e.g., a drug or device) effects. For clinicians, the end result is a bit of a “data desert” when it comes to making decisions. The new research infrastructure proposed in this book will help the medical profession to make ethically sound and well informed decisions for their patients.

The Textbook of Pharmacoepidemiology provides a streamlined text for evaluating the safety and effectiveness of medicines. It includes a brief introduction to pharmacoepidemiology as well as sections on data sources, methodology and applications. Each chapter includes key points, case studies and essential references. One-step resource to gain understanding of the subject of pharmacoepidemiology at an affordable price Gives a perspective on the subject from academia, pharmaceutical industry and regulatory agencies Designed for students with basic knowledge of epidemiology and public health Includes many case studies to illustrate pharmacoepidemiology in real clinical setting

This User’s Guide is a resource for investigators and stakeholders who develop and review observational comparative effectiveness research protocols. It explains how to (1) identify key considerations and best practices for research design; (2) build a protocol based on these standards and best practices; and (3) judge the adequacy and completeness of a protocol. Eleven chapters cover all aspects of research design, including: developing study objectives, defining and refining study questions, addressing the heterogeneity of treatment effect, characterizing exposure, selecting a comparator, defining and measuring outcomes, and identifying optimal data sources. Checklists of guidance and key considerations for protocols are provided at the end of each chapter. The User’s Guide was created by researchers affiliated with AHRQ’s Effective Health Care Program, particularly those who participated in AHRQ’s DEcIDE (Developing Evidence to Inform Decisions About Effectiveness) program. Chapters were subject to multiple internal and external independent reviews. More more information, please consult the Agency website: www.effectivehealthcare.ahrq.gov)

A concise introduction to the study of medication utilization and safety in large populations of people Understanding Pharmacoepidemiology is a clear, engagingly written roadmap to mastering the important concepts and methods of pharmacoepidemiology. It explains what pharmacoepidemiology is, how pharmacoepidemiology studies are conducted, and how to interpret findings. You will learn the importance of pharmacoepidemiology, basic terminology used in research, and the data sources, study designs, and statistical analyses employed in pharmacoepidemiology research. Upon completing Understanding Pharmacoepidemiology you will have a better understanding of how to evaluate the associations between medication utilization and outcomes. Each chapter includes these valuable learning aids: A list of learning objectives Case studies or examples Discussion questions Tables and Figures You will also find a glossary of important words and terms. The content you need to understand the concepts and methods of pharmacoepidemiology: Introduction to Pharmacoepidemiology: Principles of Epidemiology Applied to the Study of Medication Use, Study Designs in Pharmacoepidemiology: Using Secondary Data in Pharmacoepidemiology; Biostatistics and Pharmacoepidemiology: Other Methodological Issues; Evaluation of Pharmacoepidemiology Literature; Medication Utilization Patterns; Medication Safety and Pharmacovigilance; and FDA Perspectives on Post-market Drug Safety.

Drug Utilization Research (DUR) is an eclectic scientific discipline, integrating descriptive and analytical methods for the quantification, understanding and evaluation of the processes of prescribing, dispensing and consumption of medicines and for the testing of interventions to enhance the quality of these processes. The discipline is closely related and linked mainly to the broader field of pharmacoepidemiology, but also to health outcomes research, pharmacovigilance and health economics. Drug Utilization Research is a unique, practical guide to the assessment and evaluation of prescribing practices and to interventions to improve the use of medicines in populations. Edited by an international expert team from the International Society for Pharmacoepidemiology (ISPE), DUR is the only title to cover both the methodology and applications of drug utilization research and covers areas such as health policy, specific populations, therapeutics and adherence.