title: Conducting economic evaluations alongside multinational clinical trials: toward a research consensus.
abstract: Demand for economic evaluations in multinational clinical trials is increasing, but there is little consensus about how such studies should be conducted and reported. At a workshop in Durham, North Carolina, we sought to identify areas of agreement about how the primary findings of economic evaluations in multinational clinical trials should be generated and presented. In this paper, we propose a framework for classifying multinational economic evaluations according to (a) the sources of an analyst's estimates of resource use and clinical effectiveness and (b) the analyst's method of estimating costs. We review existing studies in the cardiology literature in the context of the proposed framework. We then describe important methodological and practical considerations in conducting multinational economic evaluations and summarize the advantages and disadvantages of each approach. Finally, we describe opportunities for future research. Delineation of the various approaches to multinational economic evaluation may assist researchers, peer reviewers, journal editors, and decision makers in evaluating the strengths and limitations of particular studies.
authors.affiliation: Center for Clinical and Genetic Economics, Duke University Medical Centre, Durham, NC, USA.
authors.forename: Shelby D
authors.initials: SD
authors.lastname: Reed
authors.forename: Kevin J
authors.initials: KJ
authors.lastname: Anstrom
authors.forename: Ameet
authors.initials: A
authors.lastname: Bakhai
authors.forename: Andrew H
authors.initials: AH
authors.lastname: Briggs
authors.forename: Robert M
authors.initials: RM
authors.lastname: Califf
authors.forename: David J
authors.initials: DJ
authors.lastname: Cohen
authors.forename: Michael F
authors.initials: MF
authors.lastname: Drummond
authors.forename: Henry A
authors.initials: HA
authors.lastname: Glick
authors.forename: Ari
authors.initials: A
authors.lastname: Gnanasakthy
authors.forename: Mark A
authors.initials: MA
authors.lastname: Hlatky
authors.forename: Bernie J
authors.initials: BJ
authors.lastname: O'Brien
authors.forename: Frank M
authors.initials: FM
authors.lastname: Torti
authors.forename: Anastasios A
authors.initials: AA
authors.lastname: Tsiatis
authors.forename: Andrew R
authors.initials: AR
authors.lastname: Willan
authors.forename: Daniel B
authors.initials: DB
authors.lastname: Mark
authors.forename: Kevin A
authors.initials: KA
authors.lastname: Schulman
mesh_terms: D002986:Clinical Trials as Topic / Q000191:economics* / Q000379:methods* / Q000639:trends; D003365:Costs and Cost Analysis / Q000145:classification; D005544:Forecasting; D017048:Health Care Costs / Q000145:classification*; D006295:Health Resources / Q000191:economics*; D006801:Humans; D038622:Internationality; D015337:Multicenter Studies as Topic / Q000191:economics* / Q000379:methods* / Q000639:trends; D012107:Research Design; D040841:Resource Allocation / Q000379:methods; D009626:Terminology as Topic; D016896:Treatment Outcome; D014481:United States