Abstract

the results for registration in more than one country. At the same time, this design poses a number of challenges for interpreting the resulting cost-effectiveness ratio(s). One of these challenges is whether the data required for cost-effectiveness analysis—and thus the cost-effectiveness recommendations—can be assumed to be equivalent across the different countries. In this article, a brief overview of the literature on economic analysis of multinational studies is presented. The first section relates to the background on the transferability of economic data and the second section discusses the results of a consensus conference on economic analysis of multinational trials. The third section considers the two main statistical approaches that have been advocated for handling the analysis of multinational data—fixed effect and random effect modeling methods—plus a third approach that has only recently been employed in the literature based on modeling the components of the costeffectiveness calculus. This approach is then illustrated using the results of the recently published cost-effectiveness analysis of the TOwards a Revolution in COPD Health (TORCH) trial [1]. A final section offers some conclusions for the use of such methods in comparative effectiveness and cost-effectiveness studies.

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