title: Improving the drug development process by reducing the impact of adverse events: the case of cataracts considered.
abstract: Cataract was used as a model for the prevalence and economic impact of adverse events during the drug development process. Meta-analysis revealed a reported prevalence of cataract at 12.0% (1.0-43.3%), 3.8% (2.4-12.5%), 1.0% (0.0-8.1%), 1.7% (0.0-34.8%) and 3.8% (2.3-5.7%) of compounds in preclinical, Phase I, II, III and IV clinical trials, respectively. Utilising a human-based in vitro screening assay to predict cataractogenic potential in human could allow better selection of novel compounds at early-stage drug development. This could significantly reduce costs and ultimately increase the probability of a drug obtaining FDA approval for a clinical application.
authors.affiliation: MedMetrics Inc., Ottawa, Canada; Department of Ophthalmology, King's College London, London, UK. Electronic address: Andrew.Smith@MedMetricsinc.com.
authors.forename: Andrew F
authors.initials: AF
authors.lastname: Smith
authors.affiliation: MedMetrics Inc., Ottawa, Canada.
authors.forename: Alexander
authors.initials: A
authors.lastname: Klotz
authors.affiliation: School of Biological Sciences, University of East Anglia, Norwich, UK.
authors.forename: I Michael
authors.initials: IM
authors.lastname: Wormstone
mesh_terms: D000818:Animals; D016022:Case-Control Studies; D002386:Cataract / Q000139:chemically induced* / Q000453:epidemiology; D055808:Drug Discovery / Q000191:economics; D064420:Drug-Related Side Effects and Adverse Reactions / Q000517:prevention & control; D006801:Humans; D018803:Models, Economic; D015995:Prevalence; D016032:Randomized Controlled Trials as Topic