Impact of translation availability on the patient voice in clinical trials: commentary.

Abstract

For clinical outcome assessments (COAs) to be used in global clinical trials, they must be developed in the native language of participants through the process of linguistic validation (LV). This commentary discusses why ensuring linguistic coverage might be difficult for sponsors and what consequences a lack of translated COAs might have on study data. Access to translations might be challenging due to issues with the licensing of available translations, incorporating translation development processes into study timelines, or not foreseeing language needs of each study during the planning phase. In consequence, poor quality translations might be used, or certain countries or regions might not be included at all, leading to missing data and limitations to the results of the study. To prevent these negative consequences to study data, COAs should be included in the study planning as early as possible, giving all stakeholders adequate time to fulfill any licensing requirements as well as to properly develop measures in other languages to ensure conceptual equivalence and data comparability to support pooling of data across countries. By improving communication and expectations across stakeholders involved in the licensing and translation of COAs for clinical trials, translations will be more widely available for the participants who need them, increasing the presence of the patient voice in clinical trials.