Use of Random Effect Models in the Design and Analysis of Multi-regional Clinical Trials


Journal Article

In recent years, global collaboration has become a commonly used strategy for new drug development. To accelerate the development process and shorten the approval time, the design of multi-regional clinical trials (MRCTs) incorporates subjects from many countries around the world under the same protocol. After showing the overall efficacy of a drug in all global regions, one can also simultaneously evaluate the possibility of applying the overall trial results to all regions and subsequently support drug registration in each of them. Several statistical methods have been proposed for the design and evaluation of MRCTs. Most of these approaches, however, assume a common variability of the primary endpoint across regions. In practice, this assumption may not be true due to differences across regions. In this paper, we use a random effect model for modeling heterogeneous variability across regions for the design and evaluation of MRCTs. © Springer Science+Business Media New York 2013.

Full Text

Duke Authors

Cited Authors

  • Wu, YJ; Tan, TS; Chow, SC; Hsiao, CF

Published Date

  • October 28, 2013

Published In

Volume / Issue

  • 55 /

Start / End Page

  • 325 - 344

Electronic International Standard Serial Number (EISSN)

  • 2194-1017

International Standard Serial Number (ISSN)

  • 2194-1009

Digital Object Identifier (DOI)

  • 10.1007/978-1-4614-7846-1_26

Citation Source

  • Scopus