Pharmacoepidemiology and Pharmacovigilance: Synergistic Tools to Better Investigate Drug Safety examines the role of pharmacoepidemiologic studies in drug development and its use as a prevention tool in pharmacovigilance activities. The book introduces the various epidemiologic tools and study designs commonly used for the surveillance of drug-related adverse effects and reviews the strengths and weaknesses of each. Criticisms surrounding pharmacoepidemiologic research and issues that often interfere or complicate the conduct and interpretation of these studies are also explored. Case studies illustrate the passive and active surveillance of adverse drug reactions in clinical situations, covering important pharmacoepidemiologic concepts like health risk management and safety.
The book helps pharmaceutical industry groups engaged in drug safety, clinical investigators, medical evaluators and those seeking regulatory approval enhance the safety of the drug development process for all patient populations.
- Describes the main prevention tools for the passive and active surveillance of adverse effects associated with drugs
- Provides examples of diseases in various contexts related to clinical studies and the analysis of adverse drug reactions
- Offers case studies that illustrate real-life clinical situations
- Discusses important concepts related to pharmacoepidemiology and pharmacovigilance
Pharmaceutical industry personnel (especially those working in drug safety), clinical investigators, medical evaluators, those seeking regulatory approval. Students and professors in Clinical Pharmacology, Epidemiology, and Pharmacovigilance
Chapter 1: Introduction
This chapter will provide a brief introduction on Pharmaco-epidemiology and outline the objectives for this text
Chapter 2: The role of pharmacoepidemiologic research in drug development
This chapter outlines how the discipline of Pharmaco-epidemiology fits into and can be applied within the drug development process
Chapter 3: Pharmaco-epidemiology in the prevention of adverse drug reactions.
This chapter includes the major content of the book which includes a brief overview of the main prevention tools for passive and active surveillance of adverse effects associated with drugs. This chapter includes the following sub-sections:
- Passive surveillance methods:
Spontaneous reporting of adverse drug reactions, case series reports, Periodic Safety Update Reports, Periodic Benefit Risk Evaluation Reports, Risk Management Plan, Development Safety Update Reports)
- Active surveillance methods:
- The necessity of Pharmaco-epidemiology:
Outlining the need for Pharmaco-epidemiology in the drug development process
- Tools for Safety Research in Pharmacoepidemiology Qualitative and quantitative detection of signals
- Observational study designs used in pharmacoepidemiology
Research; prospective cohort study; retrospective cohort study; case-control study; cross-sectional study; nested case-control study, case-cohort study, self-control study
- Bias and confounding factors
Selection bias; information bias; confounding factors
-Critical appraisal in pharmaco-epidemiology research
- Data sources for Pharmacoepidemiology research
- Experimental study designs
Large simple trial; N-of-1 trial
- Literature reviews; Systematic reviews; Meta-analyses
Chapter 4: Case Studies
This chapter illustrates, in a more concrete way, the information provided in the first sections of this book. Each case study illustrates a ‘real-life’ scenario and is composed of questions and answers based on appropriate clinical situations in order to provide all the necessary tools to all the partners involved in the passive and active surveillance of adverse drug reactions. These case studies also discuss important concepts related to pharmaco-epidemiology including Health Risk Management and safety measures; disproportionality analysis in spontaneous case reporting; and the use of superiority trials to establish drug safety and others.
- No. of pages:
- © Academic Press 2019
- 18th October 2018
- Academic Press
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Sabrina Nour is a Clinical Evaluator and Epidemiologist where she is in charge of reviewing the efficacy and safety of biological products. She holds a Master’s degree in epidemiology and a certificate in population risk evaluation and health management. Sabrina has acquired more than 6 years of experience working on drug safety and pharmacovigilance, including pharmacoepidemiology. Her major interests lie in pharmacoepidemiology methodology, pharmacovigilance activities, and in the influence of health policies on populations.
Pre-Market Scientific Evaluator and Epidemiologist, Health Canada, Montreal, Canada
Dr. Plourde is a senior clinic evaluator for the Health Canada’s regulatory agency. He is an associate professor in the department of clinical pharmacology and physiology, Faculty of Medicine at the University of Montreal and at the school of physical activity sciences, Faculty of Health Sciences at the University of Ottawa. He holds a doctorate in medicine (MD) from the University of Montreal and a PhD in experimental medicine from Laval University. His studies led him to publish several articles in highly rated peer-reviewed journals and to make numerous presentations for prestigious national and international associations. He has more than 12 years’ experience working on drug safety, especially for biologic products involved in the treatment of various cancers. He has also supervised many students and employees interested in the prevention of the adverse effects of health products both in clinical research and/or when health products have obtained marketing authorization.
Senior Clinic Evaluator for Health Canada’s regulatory agency; Associate Professor, Department of Clinical Pharmacology and Physiology, University of Montreal, Canada and Associate Professor, School of Physical Activity Science, University of Ottawa, Canada