Cognitive assessment is a powerful tool to illuminate the effects of investigational therapies in CNS diseases. Tests of cognitive functioning, however, are nuanced and complex, and require a high level of clinical skill as well as hands-on assessment experience to achieve proper administration. Deployment of cognitive tests in global clinical trials is further complicated by considerable cultural bias inherent in traditional cognitive assessment. Since cognitive scales are mostly developed for use in English-speaking, Western contexts, the use of translated tests with patients in other cultural-linguistic groups can be problematic.
Gathering valid and reliable data from cognitive testing in international, multi-country clinical trials requires the expert oversight of highly specialized clinicians who are well-versed in the complexities of cognitive assessment. These clinicians should have native-level awareness of the cultural-linguistic context in which testing will be conducted. Specialized clinician teams of Local Expert Advisors, sometimes referred to as “LEADs,” should be retained and utilized throughout the lifecycle of clinical research studies involving cognition. LEADs can provide expert input for scale selection and translation, training of site raters, formal evaluation of raters’ skills mastery with real-time feedback, and much more. In decentralized trial formats—or studies involving particularly complex scales—LEADs may take on the role of clinical rater and directly deliver cognitive assessments to study subjects.
Appropriate utilization of clinical and linguistic experts helps ensure high-quality data is gathered from cognitive assessments in global trials. In this webinar, Cogstate’s Dr. Svenja Wacker describes considerations for successful cognitive assessment in global trials and share how clinical trial teams can benefit from local expert clinicians supporting their CNS research. As a bilingual (German/English), licensed clinical neuropsychologist with vast experience in clinical trial management, Dr. Wacker shares hands-on experiences and best practices.
What will you learn
- Learn about the unique challenges of cognitive assessment in global clinical research
- Learn about inherent cultural bias in cognitive assessment
- Learn about important contributions of local expert clinicians to data quality in cognitive endpoint assessments
Svenja Wacker, PhD
Science Director, Business Development
Licensed Clinical Neuropsychologist