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CASE STUDY: Linguistic Validation of PROs for Drug Trial

Japanese pharmaceutical partners with Welocalize in a drug trial across 50 countries and in over 40 languages.

This case study highlights how a private Japanese pharmaceutical company collaborated with Welocalize to support its global clinical trial to measure the effectiveness of a new psychiatric drug. The trial was conducted across 50 countries and in 40 languages.

Together, we achieved:

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The Challenge 

Our client, a private Japanese pharmaceutical company, was conducting a 50-country clinical study to measure the effectiveness of a new psychiatric drug.  

Instruments used to gather data directly from the patients – patient-reported outcomes (PROs) – must be translated into the patient’s native language. For an instrument to be used in international studies, it must address the same concepts in all languages to make it possible to pool data and compare results across countries, avoiding inconsistencies.  

The client required PROs to be translated into 40 languages for the 50-country drug trial. These translations needed to be linguistically validated through pilot testing involving actual participants, conducted via culturally sensitive focus groups in 40 languages across more than 20 countries. 

The Solution 

To successfully pool data across the multinational clinical trials, Welocalize worked with multiple teams of local, native-language translators and focus groups to ensure accuracy across languages, dialects, and cultures.

More than one forward translation of the instruments was conducted, and these translations were then reconciled into a single forward translation using the best components of each. Another team then completed a back translation into English, which was then compared to the original source file.

Based on these findings, mistakes or ambiguities were corrected. Then, the single language file was culturally adapted into the local dialects. 

Cognitive Debriefing 

With so many linguistic differences and cultural nuances – even within the same trial country – it was crucial to validate trial documents for linguistic and cultural accuracy.

To test the translation or validate the accuracy of an instrument, Welocalize performed cognitive debriefing of the translation on real people.

The focus group, run by a moderator, consisted of people from diverse economic, educational, and demographic backgrounds to make up the general population for the testing.  

The Results