Current statistics indicate that a large portion of clinical trials take place outside of the United States and Western Europe, formerly the most dominant locations for clinical sites. In 2008, 78% of patients participating in U.S. clinical trials were from outside of the United States, and between 2005 and 2009, 61% of patients participating in Western European trials were from countries outside of Western Europe.

Currently 50% of all clinical trials use EDC technology. Despite the fact that most of these sites continue to be in the United States and Western Europe, the situation is changing as the number of trials conducted outside of these regions increases. Along with the growing numbers of international subjects, especially in emerging regions, there are several limitations in converting from paper-based to EDC systems that must be addressed.

Since most of  EDC systems were originally constructed in English, they must be translated into many other languages. Moreover, translation of these materials must overcome several significant challenges. We present a standardized approach for translation as well as a process for creating effective multilingual systems. In addition, we offer a summary of recommended best practices in the translation of culturally sensitive materials such as patient reported outcomes (PROs), and discuss the keys factors in EDC adoption.

If you would like more information regarding this topic please email us at translate@languageconnections.com!