Multiregional Clinical Trials: An Introduction From an Industry Perspective

Clinical trials across multiple regions of the world have become common practice, with the ultimate goal to bring good medical products to patients around the world, as fast as scientifically possible. While these trials offer access to diverse patient populations, they are not without logistical challenges, including issues related to the quality of trial conduct, data validity, and the relevance of a single large confirmatory trial. In September 2008, PhRMA sanctioned a Key Issue Team (KIT) to examine issues relevant to multiregional clinical trials (MRCTs). The MRCT KIT formed four work streams that have contributed the five articles in this special section of this issue of the journal. As guest editors for these articles, as well as cochairs of the PhRMA MRCT KIT, we provide this introductory overview of industry perspective on MRCT to serve as background for the more focused articles that follow.