title: BayesWeb: a user-friendly platform for exploratory Bayesian analysis of safety signals from small clinical trials.
abstract: Safety signals observed in early-phase clinical trials can have profound implications for the development of new medical products. It is difficult to interpret the occurrence of safety signals in small clinical trials, where formal inferential procedures may be impractical. We advocate wider use of simple Bayesian methods to explore and understand safety signals from small clinical trials. We describe a new web-based application, BayesWeb.com, that makes such exploratory Bayesian methods accessible to subject-matter experts. We illustrate the use of this software with an example from a hypothetical phase I trial for a Factor VIII product for patients with hemophilia A.
authors.affiliation: Center for Biologics Evaluation and Research, U. S. Food and Drug Administration, Rockville, MD 20852, USA. John.Scott@fda.hhs.gov
authors.forename: John A
authors.initials: JA
authors.lastname: Scott
authors.forename: Austin L
authors.initials: AL
authors.lastname: Hand
authors.forename: Layla S
authors.initials: LS
authors.lastname: Sian
mesh_terms: D001499:Bayes Theorem; D017321:Clinical Trials, Phase I as Topic / Q000379:methods* / Q000706:statistics & numerical data; D003029:Coagulants / Q000627:therapeutic use*; D003198:Computer Simulation / Q000706:statistics & numerical data*; D064420:Drug-Related Side Effects and Adverse Reactions; D005169:Factor VIII / Q000627:therapeutic use*; D006467:Hemophilia A / Q000628:therapy; D006801:Humans; D020407:Internet; D008962:Models, Theoretical; D061214:Patient Safety; D012107:Research Design / Q000706:statistics & numerical data*; D012984:Software
chemical_list: D003029:Coagulants; D005169:Factor VIII