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Research Methods for Pharmacoepidemiology Studies

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Essentials of Clinical Research

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Abstract

Pharmacoepidemiology (PE) is the discipline that studies the frequency and distribution of health and disease in human populations, as a result of the use and effects (beneficial and adverse) of drugs. PE uses methods similar to traditional epidemiologic investigation, but applies them to the area of clinical pharmacology. This chapter will review the factors involved in the selection of the type of pharmacoepidemiologic study design, and advantages and disadvantages of these designs. Since other chapters describe randomized clinical trials in detail, we will focus on observational studies.

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Author information

Authors and Affiliations

  1. Center for Clinical Epidemiology and Biostatistics, University of Pennsylvania, Philadelphia, PA, USA

    Maribel Salas M.D., D.Sc., M.Sc.

  2. Worldwide Safety Strategy, Pfizer Inc, Collegeville, PA, 19426, USA

    Maribel Salas M.D., D.Sc., M.Sc.

  3. Department of Epidemiology and Biostatistics, Erasmus University Medical School, Rotterdam, The Netherlands

    Bruno Stricker M.D., Ph.D.

  4. Drug Safety Unit, Inspectorate for Health Care, The Hague, The Netherlands

    Bruno Stricker M.D., Ph.D.

Authors
  1. Maribel Salas M.D., D.Sc., M.Sc.
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  2. Bruno Stricker M.D., Ph.D.
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Correspondence to Maribel Salas M.D., D.Sc., M.Sc. .

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Editors and Affiliations

  1. Division of Preventive Medicine, University of Alabama at Birmingham, Birmingham, Alabama, USA

    Stephen P. Glasser

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Salas, M., Stricker, B. (2014). Research Methods for Pharmacoepidemiology Studies. In: Glasser, S. (eds) Essentials of Clinical Research. Springer, Cham. https://doi.org/10.1007/978-3-319-05470-4_12

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