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Volume 76, March 2009 |
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Tips & Tools Clinical research is undergoing the same globalization process as other industries. Pharmaceutical companies are increasingly shifting clinical trials to emerging markets. Some of the factors influencing the shift in location include: Substantial cost savings; shortened timeline for clinical testing; and regulatory barriers for drug approval in the United States. As the number of clinical trials continues to grow outside of the U.S., specifically designed questionnaires are used to gather data directly from the patients. These questionnaires, called Patient-Reported Outcome (PRO) instruments, must be translated into the patient"s language. In order for a PRO instrument to be used in international studies, it must address the same concepts in all languages in order to make it possible to pool data and compare results across countries. Global Language Solutions (GLS) recently published a case study about a project consisting of the translation of 10 PRO questionnaires used by a global pharmaceutical company in its late-phase 50-country clinical trial study. The project also included linguistic validation through pilot testing (also called cognitive debriefing) of the translated questionnaires via focus groups in 40 languages in more than 30 countries. Contact us to read the complete case study. |
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