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Editorials

Multi-regional clinical trials – What are the challenges?†‡§

Sue-Jane Wang, 
  • Pages: 171-172
  • First Published: 06 September 2010

Main Papers

Consideration of regional difference in design and analysis of multi-regional trials†‡

H. M. James Hung,  Sue-Jane Wang,  Robert T. O'Neill, 
  • Pages: 173-178
  • First Published: 07 May 2010

An optimal adaptive design to address local regulations in global clinical trials†

Xiaolong Luo,  Weichung Joe Shih,  S. Peter Ouyang,  Robert J. DeLap, 
  • Pages: 179-189
  • First Published: 22 September 2010

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

Yuki Ando,  Toshimitsu Hamasaki, 
  • Pages: 190-200
  • First Published: 24 August 2010

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

Hsiao-Hui Tsou,  Shein-Chung Chow,  K. K. Gordon Lan,  Jen-pei Liu,  Mey Wang,  Herng-Der Chern,  Low-Tone Ho,  Chao A. Hsiung,  Chin-Fu Hsiao, 
  • Pages: 201-206
  • First Published: 21 June 2010

Sample size and proportion of Japanese patients in multi-regional trials†

Kimitoshi Ikeda,  Frank Bretz, 
  • Pages: 207-216
  • First Published: 22 September 2010

Trial design issues and treatment effect modeling in multi-regional schizophrenia trials†‡§

Yeh-Fong Chen,  Sue-Jane Wang,  Ni A. Khin,  H. M. James Hung,  Thomas P. Laughren, 
  • Pages: 217-229
  • First Published: 21 May 2010

Ethical considerations in industry-sponsored Multiregional clinical trials†‡

Ekopimo Ibia,  Bruce Binkowitz,  Jean-Louis Saillot,  Steven Talerico,  Chin Koerner,  Irene Ferreira,  Anupam Agarwal,  Craig Metz,  Marianne Maman, 
  • Pages: 230-241
  • First Published: 07 September 2010

Assessing consistent treatment effect in a multi-regional clinical trial: a systematic review†

Joshua Chen,  Hui Quan,  Bruce Binkowitz,  S. Peter Ouyang,  Yoko Tanaka,  Gang Li,  Shailendra Menjoge,  Ekopimo Ibia,  for the Consistency Workstream of the PhRMA MRCT Key Issue Team , 
  • Pages: 242-253
  • First Published: 14 May 2010