Patient-reported outcome (PRO) instruments are used to gather data directly from patient self-reports. Their use in clinical trials is increasingly common. As clinical trials continue to cross borders, an instrument developed in one language or culture must be adapted or translated for use in another language or culture. When a PRO instrument is translated into another language the possibility of cultural errors and understandability issues increase; potentially impacting the study data.
Each stage of the drug’s life cycle is touched by language and culture. Cultural practices and values can affect substantially a therapy’s successful development and market adoption, influencing everything from disease diagnoses to a patient’s definition of life. 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. This is done through a series of steps involving multiple teams of translators, as well as focus groups for accuracy across languages, dialects, and cultures. Even if the translation is accurate, the target culture may place a different value on what is measured. This is particularly important to assess in multi-center clinical trials where data is pooled.
Read more about translation and cultural validation in the April 2010 issue of our e-publication, Global Communicator. In the current issue, we address cultural and linguistic differences, best practices for translation processes specific to PROs, and using focus groups.
Tags: clinical trials, drug, GCP, global, life sciences, MDD, Patient-reported outcome
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