At first blush, translations and cultural adaptations are a fraction of the cost of a clinical trial. However, if your translations become inaccurate and unreliable the expense is high and the risks are real. Unfortunately, many studies overlook the importance of understanding the cultural nuances of trial participants around the world. When translating and interpreting clinical assessments, cultural adaptations can improve the quality of translated instruments by ensuring tasks, stimuli, instructions, and scoring are appropriate for the populations of interest. More importantly, native interpretations will naturally increase the quality of your trial data, making it more likely to enhance any real signal where the assessment serves as an endpoint.
Recent results have suggested cultural adaptation can properly identify and correct instrument errors prior to use in clinical trials, yielding gains in the tool’s reliability and validity. One example of this is a recent NCT Linguistics’ case study. The study focused on the translation, localization, and validation of NeuroCog Trials’ Virtual Reality Functional Capacity Assessment Tool (VRFCAT). For international use, NCTL developed methods for culturally adapting computerized instruments, including video-game graphics depicting scenes from daily life. (e.g. inside a home, a bus stop, the grocery store, meals, etc…)
Currently, a team of certified translators is conducting in-country cognitive debriefing studies with sites in Switzerland, Italy, Russia and Poland to ensure all items are linguistically and culturally appropriate for use in clinical trials. The team is also providing in-country, content expert review to ensure preserved content validity of the culturally adapted instrument.
In the end, don’t gamble with the possibility of poor translations and costly setbacks. Make sure your trial is armed with the cultural knowledge and tools it needs to ensure efficacy, acceleration, and success.
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