Evidence generation on endpoints plays a key role in the value demonstration story. For the information captured in Clinical Outcome Assessments (COAs) to be useful, the critical data from these documents must be accurately collected and comparable across languages, cultures, and countries. We often see this process fail, not because the product is not doing well, but because the measure missed the point.
The globalization of clinical research has strong implications for outcomes measurement since psycho-modulated measures such as Patient-Reported Outcomes (PROs) or Clinician-Reported Outcomes (ClinROs) are commonly included in international clinical studies. Due to the sensitivity of such scales to culture, it is crucial to ensure that equivalence is addressed during the development of translations. This will allow data to be safely compared across countries and languages. Key Discussion Topics:
- What is Linguistic Validation and why is it important?
- Overview of Linguistic Validation processes
- Linguistic Validation versus translation
- The different approaches to COA translations based on the nature of the COAs and planned use
- Real examples of challenges encountered during Linguistic Validation