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.
Pam Ventola, PhD, Vice President, Science, Cogstate
Dr. Pam Ventola leads Cogstate’s Rare Disease and Pediatric Center for Excellence, providing strategic oversight and expert guidance throughout all stages of study planning and execution. She is also an Associate Professor at the Yale Child Study Center. As a licensed clinical psychologist, Dr. Ventola’s primary clinical expertise is in pediatric neuropsychology and specifically developmental and genetic disorders.
Who Should Attend?
Executives, directors, scientists and managers from pharma, biotech and CROs responsible for clinical development of hybrid or decentralized clinical trial solutions, including:
- Research and Development
- Clinical Operations
- Clinical Science
- Outcomes Research
- Outsourcing and Procurement
- Project Management
- Clinical Trial Planning and Optimization
- Medical Affairs
What You Will Learn
Attendees will learn about:
- Scientific and operational best practices to ensure quality and consistent data collection, positive site experiences and patient retention in trials
- Types of assessments and scales that are feasible to conduct remotely in rare disease trials
- Best practices for conducting interviews via hybrid models
- Schedule of assessment considerations
- Strategies for utilizing central raters for scoring of clinical assessments
- Operational considerations related to study requirements, scheduling visits and technology enablement
Cogstate Ltd (ASX:CGS) is a leading science and technology solutions provider dedicated to optimizing the measurement of cognition in clinical trials, academic research and healthcare. Cogstate provides enabling technologies and professional services for higher quality neuropsychological assessments and is a pioneer in commercializing rapid, reliable and highly sensitive computerized cognitive tests. Cogstate customers include the world’s leading biopharmaceutical companies; elite sporting organizations and military; physicians and patients; renowned academic institutions and public-private partnerships. For more information, please visit www.cogstate.com.