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A review of risk measures in pharmacoepidemiology with tips for statisticians in the pharmaceutical industry
Author(s) -
Quartey George,
Wang Jixian,
Kim Joseph
Publication year - 2011
Publication title -
pharmaceutical statistics
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.421
H-Index - 38
eISSN - 1539-1612
pISSN - 1539-1604
DOI - 10.1002/pst.521
Subject(s) - pharmacoepidemiology , pharmacovigilance , medicine , statistician , odds ratio , epidemiology , incidence (geometry) , pharmaceutical industry , confidence interval , actuarial science , risk analysis (engineering) , adverse effect , pharmacology , business , pathology , medical prescription , physics , optics
Pharmacoepidemiology is the study of the therapeutic effects, risk, and use of drugs in large populations, which applies epidemiological methods and reasoning. As reflected in the recent strengthening of the pharmacovigilance legislation in Europe, greater attention has been placed to epidemiological research in response to an increasing call by the public for further post‐marketing studies on the safety and efficacy of drugs. Various measures of risk are used in pharmacoepidemiology to quantify the probability of experiencing an adverse outcome and capture the relative increases in risk between treated and untreated populations: cumulative incidence, incidence rate, absolute risk reduction, relative risk, odds ratio, incidence rate ratio, and time to event outcomes. We review in this paper the commonly used measures of risk in pharmacoepidemiology and provide some practical tips for the industry statistician. Copyright © 2011 John Wiley & Sons, Ltd.