Testing Industry Assumptions About Raters’ Clinical Experience and Performance During Alzheimer’s Disease Clinical Trials

These data confirm the importance of AD-specific clinical experience and performance during pre-trial training exercises as key indicators of rater performance during clinical trials. Sponsors should consider performance during pre-trial startup activities when selecting raters to ensure that COAs are accurately scored and reliably implemented throughout the duration of the trial. Planned analyses will explore additional predictors of rater performance (e.g., individual and site level factors), as well as the implications of rater remediation on trial outcome data (i.e., impacts on data reliability).