title: Analytic considerations in economic evaluations of multinational cardiovascular clinical trials.
abstract: OBJECTIVE
  The growing number of economic evaluations that use data collected in multinational clinical trials raises numerous questions regarding their execution and interpretation. Although recommendations for conducting economic evaluations have been widely disseminated, relatively little guidance has been given for conducting economic evaluations alongside clinical trials, particularly multinational trials.
  
  
  METHODS
  Building on a literature review that was conducted in preparation for an expert workshop, we evaluated a subset of methodological issues related to conducting economic evaluations alongside multinational clinical trials.
  
  
  RESULTS
  We found wide variation in the types of costs included as part of the analyses and in the methods used to assign costs to hospitalization events. Furthermore, we found that the extrapolation of costs and survival outcomes beyond the trial period is an inconsistent practice and is often not dependent on whether a survival benefit was observed in the trial or on the epidemiology or practice patterns in the country to which the findings are directed.
  
  
  CONCLUSIONS
  Although the limited sample size precluded a quantitative analysis of trial characteristics and their associations with the methodologies employed, our findings highlight the need for more guidance to analysts regarding the execution of economic evaluations using data from multinational clinical trials. As the research community grapples with the complexities of methodological and logistical issues involved in multinational economic evaluations, the development of a standardized format to report the basic methodological characteristics of such studies would help to improve transparency and comparability for other analysts and decision-makers.
authors.affiliation: Center for Clinical and Genetic Economics, Duke Clinical Research Institute, Duke University Medical Center, Durham, NC 27715, USA.
authors.forename: Frank M
authors.initials: FM
authors.lastname: Torti
authors.forename: Shelby D
authors.initials: SD
authors.lastname: Reed
authors.forename: Kevin A
authors.initials: KA
authors.lastname: Schulman
mesh_terms: D002318:Cardiovascular Diseases / Q000191:economics* / Q000401:mortality; D003362:Cost-Benefit Analysis / Q000379:methods; D003627:Data Interpretation, Statistical; D006302:Health Services Research / Q000379:methods*; D017721:Hospital Costs; D006801:Humans; D038622:Internationality; D015337:Multicenter Studies as Topic / Q000379:methods*; D016032:Randomized Controlled Trials as Topic / Q000379:methods*; D016019:Survival Analysis; D014481:United States