Fully remote or hybrid administration of clinical outcome measures in rare disease trials is on the rise. This is because of the recognition that remote assessments reduce patient burden through efforts within the industry to increase enrollment of traditionally under-served populations. Further, many assessments in rare disease trials are complex, and remote/hybrid trials readily allow for the use of highly expert centralized raters to administer and score the scales, thereby improving data quality via a decrease in variance and an increase in reliability for data collected. While study teams wish to implement these approaches, many are unfamiliar with the operational considerations needed to be successful. Based on interviews with site staff and key opinion leaders as well as first-hand experience with remote central rating in many international clinical trials featured speaker Dr. Pam Ventola will share newly developed guidance for remote centralized rating of standardized rare disease assessments. Attendees will gather best practices to ensure quality and consistent data collection, positive site experiences and patient retention via appropriate scale/technology requirements, schedule of assessments, central rater preparation & training and operational approaches. Register to gain insights into the newly developed guidance on reducing site/patient burden and improving data quality in remote rare disease trials.

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Remote Care Technology

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