Reducing Linguistic Validation Timeline for Alzheimer’s Trial
Delivering nine Clinical Outcome Assessments (COAs) for patients with cognitive impairments
Overview
The project involved nine Clinical Outcome Assessments (COAs) for patients with cognitive impairments. COAs are critical endpoints in the study, requiring a rigorous methodology to ensure precise data capture and quality. The Linguistic Validation Project Manager plays a pivotal role in ensuring translation accuracy.
Solution
Language solutions
Industry
Pharmaceuticals
The problem
The initial estimate from the sponsor was two weeks for the translation, not accounting for the comprehensive linguistic validation process required for COAs. Normally, such a project would take 16-20 weeks.
Additional challenges came from the source COAs, which included cognitive batteries assessing patients' cognitive function, requiring input from clinicians and observers. These included recall and letter fluency tests needing alternate stimuli in non-Latin alphabets (e.g., the task of generating words starting with a specific letter, adjusted for Japanese characters).
Japanese linguistic validation posed unique challenges due to significant cultural and linguistic differences from the source language.
The solution
Linguamatics’ commitment to scientific excellence combined with agile project management allowed our Linguistic Validation team to successfully translate and validate a series of complex cognitive assessments into Japanese and US Spanish. The project was delivered on time and to a high standard.
Results
- Saving time whilst ensuring quality: The team completed the project in 12 weeks, delivering drafts in time for the Institutional Review Board. To shorten the timeline without sacrificing scientific quality, critical tasks like creating concept elaborations and reviewing back translations were divided between two experienced Project Managers, with oversight from a Lead PM for consistency. Internal linguists were prepared in advance to prioritize these files, facilitating direct communication on translation issues.
- Leveraging healthcare expertise: To further scientific expertise, Linguamaticssuggested involving a native clinician from the target therapeutic area early on, leading to minimized required discussions later. Typically, in standard COA linguistic validation, clinician review replaces patient cognitive debriefing. However, for this project, the recommendation was to include clinician input at the start, while maintaining the final review and cognitive debriefing step.
- Optimizing process: To guide the translation process, detailed concept elaborations were created and shared, along with the source questionnaires, with the clinician at the project's inception to gather their feedback on the source documents and reference materials before translation began. The clinician's deep understanding of the condition and patient population guided the translators through two forward translations, reconciliation, and back translation. The clinician review was then repeated on the Japanese translation, along with cognitive debriefing. An additional language was later added to the project, and existing documentation could be leveraged to streamline the process further.