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Considerations for Innovative Trial Design in CNS
Session Chair(s)
Christopher Edgar, PHD, MSC
Chief Scientific Officer
Cogstate, United States
It is clear that what was a slow trend towards decentralized healthcare and clinical research has recently undergone a major inflection point due to the COVID-19 pandemic and consequently, the ability to support decentralized trials and implement remote and unsupervised assessments is a high priority. Clinical outcomes assessments (COAs) may present unique challenges, but also important opportunities related to their suitability and validity for remote conduct, as well as their practical implementation. The continued and successful application of both traditional clinical evaluations and emerging digital technologies is critical to the evaluation of novel therapies and consequently, the field must identify and promote good practice in this area.
Learning Objective : Review practical examples and case studies of remote and decentralized clinical trial implementation; Identify good practice in the validation and implementation of clinical outcome assessments (COAs) including clinician reported outcome (ClinRO), performance outcome (PerfO), and Digital Health Technology (DHT)/Passive Monitoring assessments.
Speaker(s)
Precision Motion Wearables Technology and Patient Centricity: A Match Made for Hybrid and Decentralized Trials
Kristen Sowalsky, PHD
Clario, United States
Director, Clinical Science and Consulting - Wearables and Digital Biomarkers
Implementing A Fully Decentralized Clinical Trial for Major Depression
Chris Reist, MD, MBA
Science 37, United States
Medical Director, Psychiatry and Behavioral Science
The Rater will Zoom You Now: Considerations for Equivalency, Reliability, and Feasibility of Remote ClinRO Assessments
Daniel Debonis
EMA Wellness, United States
Chief Product Officer