title: Biostatistical considerations in pharmacovigilance and pharmacoepidemiology: linking quantitative risk assessment in pre-market licensure application safety data, post-market alert reports and formal epidemiological studies.
abstract: This paper deals with a conceptual discussion of a variety of statistical concepts, methods and strategies that are relevant to the quantitative assessment of risk derived from safety data collected during the pre- and post-marketing phase of a new drug's life cycle. A call is made for the use of more standard approaches to the analysis of safety data that are statistically and epidemiologically rigorous and for attempts to link the strategies for pre-market safety assessment with strategies for post-market safety evaluation. This link may be facilitated by recognizing the limitations and complementary roles played by pre- and post-market safety data collection schemes and by linking the quantitative analyses utilized for either exploratory or confirmatory purposes of risk assessment in each phase of safety data collection. Examples are provided of studies specifically designed to evaluate risk in a post approval setting and several available guidelines intended to improve the quality of these studies are discussed.
authors.affiliation: Food and Drug Administration, Division of Biometrics, Rockville, MD 20857, USA.
authors.forename: R T
authors.initials: RT
authors.lastname: O'Neill
mesh_terms: D003625:Data Collection; D003627:Data Interpretation, Statistical; D016208:Databases, Factual; D004341:Drug Evaluation / Q000592:standards*; D017408:Guidelines as Topic; D006801:Humans; D008004:Licensure; D017891:Pharmacoepidemiology / Q000592:standards*; D011358:Product Surveillance, Postmarketing / Q000592:standards*; D015203:Reproducibility of Results; D012107:Research Design / Q000592:standards; D018570:Risk Assessment / Q000592:standards*