Proposals of statistical consideration to evaluation of results for a specific region in multi-regional trials--Asian perspective.

Journal Article (Journal Article)

In recent years, global collaboration has become a conventional strategy for new drug development. To accelerate the development process and to shorten approval time, the design of multi-regional trials 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. Recently, the trend for simultaneous clinical development in Asian countries being undertaken simultaneously with clinical trials conducted in Europe and the United States has been rapidly rising. In this paper, proposals of statistical consideration to multi-regional trials are provided. More specifically, three aspects are addressed: the definition of the 'Asian region,' the consistency criterion between the 'Asian region' and the overall regions, and the sample size determination for the multi-regional trial.

Full Text

Duke Authors

Cited Authors

  • Tsou, H-H; Chow, S-C; Lan, KKG; Liu, J-P; Wang, M; Chern, H-D; Ho, L-T; Hsiung, CA; Hsiao, C-F

Published Date

  • July 2010

Published In

Volume / Issue

  • 9 / 3

Start / End Page

  • 201 - 206

PubMed ID

  • 20568264

Electronic International Standard Serial Number (EISSN)

  • 1539-1612

Digital Object Identifier (DOI)

  • 10.1002/pst.442


  • eng

Conference Location

  • England