title: Designs to balance cost and success rate for an early phase clinical study.
abstract: We present an initial exploration of a fully cost-driven design. A design criterion was proposed that represented the minimum expected cost of an early phase clinical study, where costs include resource use as well as study failure. The design was based on attainment of a target concentration in a cohort of study participants. The model and parameter values arose from a previous population pharmacokinetic analysis of a phase I study. The resulting design naturally balanced the cost and the success rate of an early phase clinical study, without the need to define arbitrary constraints on the design space.
authors.affiliation: a Faculty of Computing and Informatics , Multimedia University , Cyberjaya , Selangor , Malaysia.
authors.forename: Lee Kien
authors.initials: LK
authors.lastname: Foo
authors.affiliation: b School of Pharmacy , University of Otago , Dunedin , Otago , New Zealand.
authors.forename: Stephen
authors.initials: S
authors.lastname: Duffull
mesh_terms: D017321:Clinical Trials, Phase I as Topic / Q000191:economics*; D006801:Humans; D010599:Pharmacokinetics; D012107:Research Design
keywords: Clinical study; cost optimal design; pharmacokinetic