title: Economic evaluations during early (phase II) drug development: a role for clinical trial simulations?
abstract: Faced with increasing demands on demonstrating cost effectiveness, pharmaceutical companies are required to conduct pharmacoeconomic evaluations throughout the drug development programme. At present, there is particular emphasis in the literature on burden-of-illness studies and on economic evaluations conducted alongside phase III clinical trials but not on those conducted during phase II clinical trials. This article describes modelling techniques, namely clinical trial simulations (CTS), which are gaining popularity in the clinical research community, but which might also prove to be beneficial during the conduct of these early pharmacoeconomic evaluations. The basic concepts and structure of CTS are described by using published examples of simulations of antipsychotic and anticancer drugs. With the use of an illustrative example of a hypothetical cholinesterase inhibitor for Alzheimer's disease, an integrated CTS-based pharmacoeconomic evaluation is presented. The results demonstrate how the modelling may be of value in 'go/no-go' decisions during the drug development programme.
authors.affiliation: Prescribing Research Group, Department of Pharmacology and Therapeutics, University of Liverpool, Liverpool, UK. dyfrig@liv.ac.uk
authors.forename: D A
authors.initials: DA
authors.lastname: Hughes
authors.forename: T
authors.initials: T
authors.lastname: Walley
mesh_terms: D014150:Antipsychotic Agents / Q000191:economics / Q000627:therapeutic use; D002986:Clinical Trials as Topic / Q000191:economics*; D003198:Computer Simulation; D003362:Cost-Benefit Analysis; D003987:Dibenzothiazepines / Q000191:economics / Q000627:therapeutic use; D015195:Drug Design; D004345:Drug Industry / Q000191:economics*; D017850:Economics, Pharmaceutical; D006801:Humans; D000069348:Quetiapine Fumarate
chemical_list: D014150:Antipsychotic Agents; D003987:Dibenzothiazepines; D000069348:Quetiapine Fumarate