title: A review of risk measures in pharmacoepidemiology with tips for statisticians in the pharmaceutical industry.
abstract: 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.
authors: Roche Products Ltd - Statistical Methods and Research, 6 Falcon Way, Welwyn Garden City, AL7 1TW, United Kingdom. george.quartey@roche.com
authors: George
authors: G
authors: Quartey
authors: Jixian
authors: J
authors: Wang
authors: Joseph
authors: J
authors: Kim
mesh_terms: D004345:Drug Industry / Q000706:statistics & numerical data*; D006801:Humans; D017891:Pharmacoepidemiology / Q000706:statistics & numerical data*; D011358:Product Surveillance, Postmarketing / Q000706:statistics & numerical data*; D018570:Risk Assessment / Q000706:statistics & numerical data*