Designs to balance cost and success rate for an early phase clinical study

Foo, Lee Kien and Duffull, Stephen (2016) Designs to balance cost and success rate for an early phase clinical study. Journal of Biopharmaceutical Statistics. pp. 1-11. ISSN 1054-3406

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Official URL: http://doi.org/10.1080/10543406.2016.1148703

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.

Item Type: Article
Uncontrolled Keywords: Clinical study, cost optimal design, pharmacokinetic
Subjects: T Technology > T Technology (General)
Divisions: Faculty of Computing and Informatics (FCI)
Depositing User: Ms Rosnani Abd Wahab
Date Deposited: 02 Feb 2017 09:39
Last Modified: 02 Feb 2017 09:39
URI: http://shdl.mmu.edu.my/id/eprint/6411

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