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[Economic analysis of multinational clinical trials in oncology].

作者信息

Lejeune Catherine, Lueza Béranger, Bonastre Julia

机构信息

Université Bourgogne Franche-Comté-Inserm CIC1432, module épidémiologie clinique, 7, boulevard Jeanne-d'Arc, 21000 Dijon, France; Centre hospitalier universitaire, centre d'investigation clinique, module épidémiologie clinique/essais cliniques, 7, boulevard Jeanne-d'Arc, BP 87900, 21000 Dijon, France; Université de Bourgogne et Franche-Comté, EPICAD LNC-UMR1231, 7, boulevard Jeanne-d'Arc, BP 87900, 21000 Dijon, France.

Université Paris-Saclay, Gustave-Roussy, service de biostatistique et d'épidémiologie, 94805 Villejuif, France; Université Paris-Sud, UVSQ, université Paris-Saclay, Oncostat CESP, Inserm, 94085 Villejuif, France.

出版信息

Bull Cancer. 2018 Feb;105(2):204-211. doi: 10.1016/j.bulcan.2017.10.027. Epub 2018 Feb 21.

Abstract

In oncology, as in other fields of medicine, international multicentre clinical trials came into being so as to include a sufficient number of subjects to investigate a clinical situation. The existence of tight budgetary constraints and the desire to make the best use of the resources available have resulted in the development of economic evaluations associated with these trials, which, thanks to their level of evidence and their size, provide particularly relevant material. Nonetheless, economic evaluations alongside international clinical trials raise specific questions of methodology with regard to both the design and the analysis of the results. Indeed, the costs of goods and services consumed, the types and quantities of resources, and medical practices vary from one country to another and within an individual country. Economic data from the different countries involved must be available so as to study and to take into account this variability, and appropriate techniques for cost estimations and analysis must be implemented to aggregate the results from several countries. From a review of the literature, the aim of this work was to provide an overview of the specific methodological features of economic evaluations alongside international clinical trials: analysis of efficacy data from several countries, collection of resources and real costs, methods to establish the monetary value of resources, methods to aggregate results accounting for the trial effect.

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