Clinical trials are conducted around the world to evaluate the safety and efficacy of new drugs, devices, and treatments. These trials often involve participants from different linguistic and cultural backgrounds, making accurate translations essential for ensuring participant understanding and data quality. In particular, electronic patient-reported outcome (ePRO) and electronic clinical outcome assessment (eCOA) measures have become increasingly common in clinical trials, making an accurate translation of these measures crucial for success.
Translation errors in clinical trials can lead to inaccurate data collection, increased risk to participants, and ultimately, hinder regulatory approval of the study drug or device. Therefore, it is essential to ensure that all translations are of high quality, accurate, and consistent across all languages used in the trial. The following article outlines best practices for ensuring accuracy and consistency in translations for ePRO and eCOA measures in clinical trials.
Translation Best Practices for ePRO/eCOA Measures
Use Standardized Tools
Standardized tools such as glossaries, style guides, and translation templates can help ensure that translations are accurate and consistent across all languages used in the trial. This also helps ensure that translations adhere to regulatory requirements for clinical trials.
Use Experienced Linguists
Linguists with experience in the medical field, specifically with ePRO/eCOA measures, are critical for ensuring that translations are accurate and consistent with the original source material. Experienced linguists help ensure that translations are culturally appropriate for the target population.
Employ Back Translation
Back translation involves translating the target language back into the source language to ensure accuracy and consistency. This process can reveal translation errors and help ensure that translations accurately reflect the original source material.
Establish Translation Memory
A translation memory is a customer-specific database of previously translated terms and phrases. When applied to ePRO/eCOA measures, a TM can help ensure consistency from study to study as well as reduce costs.
Conduct Cognitive Debriefing
When recommended, cognitive debriefing involves administering translated questionnaires to a sample of participants and collecting feedback on the clarity, accuracy, and relevance of the translations. This process can help ensure that translations are culturally relevant and appropriate for the target population.
The Impact of ePRO/eCOA Translation Errors in Clinical Trials
The impact of ePRO/eCOA translation errors in clinical trials can be significant. Translation errors can lead to inaccurate data collection, which can ultimately affect the safety and efficacy of the study drug or device. In addition, translation errors can cause confusion and frustration for participants, which can lead to dropouts and affect the validity of the trial results.
Furthermore, regulatory agencies such as the FDA and EMA require that translations for clinical trials are accurate, consistent, and culturally appropriate. Therefore, it is essential to invest in high-quality translation services to ensure compliance with these regulations and prevent costly delays in regulatory approval.
Conclusion
Accurate translation is crucial for the success of clinical trials, particularly in the context of ePRO/eCOA measures. By employing best practices such as using experienced linguists, conducting cognitive debriefing, and using standardized tools, trial sponsors can ensure that translations are accurate, consistent, and culturally appropriate. Investing in high-quality translation services can help ensure regulatory compliance, prevent costly delays in regulatory approval, and ultimately improve patient outcomes.
References
FDA Guidance for Industry: Patient-Reported Outcome Measures: Use in Medical Product Development to Support Labeling Claims. Retrieved from https://www.fda.gov/media/77832/download
EMA Reflection paper on the regulatory guidance