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Sunday, June 20 • 12:00pm - 1:00pm
#540 OD: Considerations for Innovative Trial Design in CNS

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Component Type: Session
Level: Intermediate

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 Objectives

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.

Chair

Christopher Edgar, PhD, MSc

Speaker

Precision Motion Wearables Technology and Patient Centricity: A Match Made for Hybrid and Decentralized Trials
Kristen Sowalsky, PhD

Implementing A Fully Decentralized Clinical Trial for Major Depression
Chris Reist, MD, MBA

The Rater will Zoom You Now: Considerations for Equivalency, Reliability, and Feasibility of Remote ClinRO Assessments
Daniel Debonis



Speakers
DD

Daniel Debonis

Principal, Signant Health, United States
Dan is a founder and leader in clinical trail technologies, with a focus in Neuroscience and data analytics. He was a founder of a company developed one of the industry's first eCOA and Endpoint Quality platform in 2005, and has served in leadership roles in product and commercial... Read More →
CR

Chris Reist

Medical Director, Psychiatry and Behavioral Science, Science 37, United States
avatar for Christopher Edgar

Christopher Edgar

Chief Scientific Officer, Cogstate, United States
Dr. Chris Edgar has an extensive background in drug development and clinical trials methodology, and is an expert in the development, validation and application of clinical outcome assessments (COAs). He has held positions as scientific director at Cognitive Drug Research Ltd, senior... Read More →
avatar for Kristen Sowalsky

Kristen Sowalsky

Director, Clinical Science and Consulting - Wearables and Digital Biomarkers, ERT, United States


Sunday June 20, 2021 12:00pm - 1:00pm EDT
TBD Virtual Event Horsham, PA 19044
  06: PreClin Dev-EarlyPhaseCR, Session |   03: Data-Data Standards, Session |   02: ClinTrials -ClinOps, Session |   20: Early Access Content, Session