title: The role of quantitative safety evaluation in regulatory decision making of drugs.
abstract: Evaluation of safety is a critical component of drug review at the US Food and Drug Administration (FDA). Statisticians are playing an increasingly visible role in quantitative safety evaluation and regulatory decision-making. This article reviews the history and the recent events relating to quantitative drug safety evaluation at the FDA. The article then focuses on five active areas of quantitative drug safety evaluation and the role Division of Biometrics VII (DBVII) plays in these areas, namely meta-analysis for safety evaluation, large safety outcome trials, post-marketing requirements (PMRs), the Sentinel Initiative, and the evaluation of risk from extended/long-acting opioids. This article will focus chiefly on developments related to quantitative drug safety evaluation and not on the many additional developments in drug safety in general.
authors.affiliation: a Division of Biometrics VII, Office of Biostatistics , Center for Drug Evaluation and Research, US Food and Drug Administration , Silver Spring , Maryland , USA.
authors.forename: Aloka G
authors.initials: AG
authors.lastname: Chakravarty
authors.affiliation: a Division of Biometrics VII, Office of Biostatistics , Center for Drug Evaluation and Research, US Food and Drug Administration , Silver Spring , Maryland , USA.
authors.forename: Rima
authors.initials: R
authors.lastname: Izem
authors.affiliation: a Division of Biometrics VII, Office of Biostatistics , Center for Drug Evaluation and Research, US Food and Drug Administration , Silver Spring , Maryland , USA.
authors.forename: Stephine
authors.initials: S
authors.lastname: Keeton
authors.affiliation: a Division of Biometrics VII, Office of Biostatistics , Center for Drug Evaluation and Research, US Food and Drug Administration , Silver Spring , Maryland , USA.
authors.forename: Clara Y
authors.initials: CY
authors.lastname: Kim
authors.affiliation: a Division of Biometrics VII, Office of Biostatistics , Center for Drug Evaluation and Research, US Food and Drug Administration , Silver Spring , Maryland , USA.
authors.forename: Mark S
authors.initials: MS
authors.lastname: Levenson
authors.affiliation: a Division of Biometrics VII, Office of Biostatistics , Center for Drug Evaluation and Research, US Food and Drug Administration , Silver Spring , Maryland , USA.
authors.forename: Mat
authors.initials: M
authors.lastname: Soukup
mesh_terms: D001699:Biometry; D006801:Humans; D007880:Legislation, Drug / Q000639:trends*; D015201:Meta-Analysis as Topic; D004364:Pharmaceutical Preparations / Q000592:standards*; D012449:Safety / Q000331:legislation & jurisprudence* / Q000592:standards*; D014481:United States; D014486:United States Food and Drug Administration
chemical_list: D004364:Pharmaceutical Preparations
keywords: Evaluation of risk from extended/long-acting opioids; large safety outcome trials; meta-analysis for safety evaluation; post-marketing requirements; quantitative safety evaluation; the sentinel initiative