Overview
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 globalisation 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
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Defining linguistic validation and its importance in clinical research
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Overview of linguistic validation processes
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Linguistic validation vs. translation
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Different approaches: is the linguistic validation process relevant for all COAs?
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Screening scales and neurocognitive scales
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Application of linguistic validation for heavily country-specific COAs (e.g. K-bit)
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Real examples of challenges encountered during linguistic validation
Speakers
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Christelle Giroudet
Christelle Giroudet has been working in the field ofclinical outcome assessmentsfor clinical research for over 25 years. She has extensive experience in her various roles in project management, proposal development, and commercial activities for linguistic validation projects.
Ana Alvarez
Ana Alvarez has been involved in the clinical research industry for over ten years with experience in tranlsation, linguistic validation of COAs, and eCOA migration. She is focused on client relationships, communications and outreach as well as proposal development for Patient Centred Sciences.
Target Audience
This webinar is designed for life science industry professionals in the following areas who implement COAs for global clinical trials:
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Clinical Operations
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COA Management
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Global Health Economics, Outcomes Research
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Clinical Trial Protocol Design
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Regulatory Affairs
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PRO Development and Implementation
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Global Market Access