title: Challenges from Variation across Regions in Cost Effectiveness Analysis in Multi-Regional Clinical Trials.
abstract: Economic evaluation in the form of cost-effectiveness analysis has become a popular means to inform decisions in healthcare. With multi-regional clinical trials in a global development program becoming a new venue for drug efficacy testing in recent decades, questions in methods for cost-effectiveness analysis in the multi-regional clinical trials setting also emerge. This paper addresses some challenges from variation across regions in cost effectiveness analysis in multi-regional clinical trials. Several discussion points are raised for further attention and a multi-regional clinical trial example is presented to illustrate the implications in industrial application. A general message is delivered to call for a depth discussion by all stakeholders to reach an agreement on a good practice in cost-effectiveness analysis in the multi-regional clinical trials. Meanwhile, we recommend an additional consideration of cost-effectiveness analysis results based on the clinical evidence from a certain homogeneous population as sensitivity or scenario analysis upon data availability.
authors.affiliation: Boehringer Ingelheim (China) Investment Co. Ltd. Shanghai, China.
authors.forename: Yunbo
authors.initials: Y
authors.lastname: Chu
authors.affiliation: Boehringer Ingelheim (China) Investment Co. Ltd. Shanghai, China.
authors.forename: Luyan
authors.initials: L
authors.lastname: Dai
authors.affiliation: Boehringer Ingelheim (China) Investment Co. Ltd. Shanghai, China.
authors.forename: Sheng
authors.initials: S
authors.lastname: Qi
authors.affiliation: Department of Health Promotion and Behavior, Institute of Gerontology, University of GeorgiaAthens, GA, USA; Texas A&M School of Public Health, Health Science Center, Texas A&M UniversityCollege Station, TX, USA.
authors.forename: Matthew Lee
authors.initials: ML
authors.lastname: Smith
authors.affiliation: Department of Probability and Statistics, Center for Statistical Science, Peking University Beijing, China.
authors.forename: Hui
authors.initials: H
authors.lastname: Huang
authors.affiliation: Center for Applied Statistics and School of Statistics, Renmin University of China Beijing, China.
authors.forename: Yang
authors.initials: Y
authors.lastname: Li
authors.affiliation: Department of Epidemiology and Biostatistics, University of Georgia Athens, GA, USA.
authors.forename: Ye
authors.initials: Y
authors.lastname: Shen
keywords: clinical evidence; cost-effectiveness analysis; ethnic factors; multi-regional clinical trials; sensitivity analysis