title: Decision rules and associated sample size planning for regional approval utilizing multiregional clinical trials.
abstract: Multiregional clinical trials provide the potential to make safe and effective medical products simultaneously available to patients globally. As regulatory decisions are always made in a local context, this poses huge regulatory challenges. In this article we propose two conditional decision rules that can be used for medical product approval by local regulatory agencies based on the results of a multiregional clinical trial. We also illustrate sample size planning for such trials.
authors.affiliation: Department of Pharmacology and Biostatistics, Shanghai JiaoTong University School of Medicine, Shanghai, China.
authors.forename: Xiaoyuan
authors.initials: X
authors.lastname: Chen
authors.forename: Nelson
authors.initials: N
authors.lastname: Lu
authors.forename: Rajesh
authors.initials: R
authors.lastname: Nair
authors.forename: Yunling
authors.initials: Y
authors.lastname: Xu
authors.forename: Cailian
authors.initials: C
authors.lastname: Kang
authors.forename: Qin
authors.initials: Q
authors.lastname: Huang
authors.forename: Ning
authors.initials: N
authors.lastname: Li
authors.forename: Hongzhuan
authors.initials: H
authors.lastname: Chen
mesh_terms: D000465:Algorithms; D002681:China; D003659:Decision Making, Organizational; D017277:Drug Approval; D004347:Drug Interactions; D004358:Drug Therapy; D006801:Humans; D007564:Japan; D015337:Multicenter Studies as Topic / Q000379:methods* / Q000706:statistics & numerical data; D012107:Research Design / Q000706:statistics & numerical data*; D018401:Sample Size