Main Paper

Practical issues and lessons learned from multi-regional clinical trials via case examples: a Japanese perspective†

  1. Yuki Ando1,‡,*,
  2. Toshimitsu Hamasaki2

Article first published online: 24 AUG 2010

DOI: 10.1002/pst.448

Issue

Pharmaceutical Statistics

Pharmaceutical Statistics

Special Issue: Special Issue: Multi-Regional Clinical Trials – What Are The Challenges?

Volume 9, Issue 3, pages 190–200, July/September 2010

Additional Information

How to Cite

Ando, Y. and Hamasaki, T. (2010), Practical issues and lessons learned from multi-regional clinical trials via case examples: a Japanese perspective. Pharmaceutical Statistics, 9: 190–200. doi: 10.1002/pst.448

Author Information

  1. 1

    Office of New Drug II, Pharmaceuticals and Medical Devices Agency, Tokyo, Japan

  2. 2

    Department of Biomedical Statistics, Osaka University Graduate School of Medicine, Osaka, Japan

  1. ‡

    Views expressed in this paper are the author's professional opinions and do not necessarily represent the official positions of the Pharmaceuticals and Medical Devices Agency, Japan.

*Office of New Drug II, Pharmaceuticals and Medical Devices Agency, Tokyo, Japan

  1. †

    This article is published in Pharmaceutical Statistics as a special issue on Multi-regional Clinical Trials–What are the challenges?, edited by Sue Jane Wang, Office of Biostatistics, Office of Translational Sciences, CDER, U.S. Food and Drug Administration, MD, USA

Publication History

  1. Issue published online: 22 SEP 2010
  2. Article first published online: 24 AUG 2010

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Keywords:

  • consistency;
  • ethnic factors;
  • dose–response relationship;
  • ICH-E5 guideline;
  • pharmacokinetic data

Abstract

The multi-regional clinical trials (MRCTs) being administered in different regions of the world now play a major role in providing evidence for the efficacy and safety of new drugs amidst the simultaneous global development and worldwide registration of such drugs, in support of the expeditious availability of medical products to patients. However, such trials present considerable challenges as far as quality, design, implementation, analysis, and interpretation are concerned. In this article, we share our observations and lessons learned from the design, implementation, analysis, and interpretation of some MRCTs with case examples. Current Japanese regulatory guidance on MRCTs is introduced along with some suggestions for design, implementation, and interpretation. Copyright © 2010 John Wiley & Sons, Ltd.

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