title: Cost-effectiveness analysis for multinational clinical trials.
abstract: Clinical trials of cost-effectiveness are often conducted in more than one country. The two most common ways of dealing with the multinational nature of the data are either to calculate a pooled estimate or to stratify results by country. Since the between-country heterogeneity in costs is potentially substantial, pooled estimates may be difficult to interpret for any one country. Policy decisions are often made at a national level, and so country-specific results are important. However, country-specific analyses will be based on fewer patients and will often fail to provide adequate precision for statistical analyses. Shrinkage estimation is a compromise between these two methods and has been used successfully in other fields. These estimates are country-specific yet less variable than those derived through a subgroup approach. Univariate and multivariate shrinkage estimators for costs and effects are proposed, then compared with one another and to the traditional methods in a simulation study. The methods are illustrated using data from a multinational trial evaluating the cost-effectiveness of three thrombolytic drug regimens in patients with acute myocardial infarction.
authors.affiliation: Program in Population Health Sciences, Research Institute, Hospital for Sick Children, 555 University Avenue, Toronto, Ontario, Canada M5G 1X8.
authors.forename: Eleanor M
authors.initials: EM
authors.lastname: Pinto
authors.forename: Andrew R
authors.initials: AR
authors.lastname: Willan
authors.forename: Bernie J
authors.initials: BJ
authors.lastname: O'Brien
mesh_terms: D002986:Clinical Trials as Topic / Q000191:economics*; D003362:Cost-Benefit Analysis / Q000706:statistics & numerical data*; D006801:Humans; D038622:Internationality; D009203:Myocardial Infarction / Q000188:drug therapy*; D009864:Ontario; D015912:Thrombolytic Therapy