Enabling remote assessments to drive patient enrollment, engagement, and retention and enhance data quality.
What was once a slow trend towards decentralized healthcare and clinical research has now undergone a major inflection point. Driven in part by challenges resulting from the COVID-19 pandemic, clinical research teams are now embracing more decentralized clinical trial (DCT) activities, progressing well beyond pandemic-related mitigation strategies.
When implemented well, remote administration of clinical outcomes assessments (COAs), such as cognitive assessments or symptom severity rating scales, bring clear benefits to trial conduct from expanding trial access and diversity to enhancing data quality. However, clinical outcomes assessments present both unique challenges and important opportunities related to their suitability and validity for remote conduct and their practical implementation. The continued and successful application of both conventional clinical evaluations and emerging digital technologies is critical to the evaluation of novel therapies, and, therefore, the field must identify and promote good practices in this area.
In working with sponsors, license holders, technology partners, and regulators, our presenters have gained important perspectives into successful implementation of remote COA administration for both computerized and conventional assessments in central nervous system (CNS) trials. During this webinar, they will outline important considerations, lessons learned and practical case examples of remote and decentralized clinical trial implementation.
Register for this webinar to learn about remote administration of COAs in decentralized clinical trials, including specific examples in major depression, Alzheimer’s disease and other indications.
Speakers
Christopher Reist, MD, MBA, Medical Director, Psychiatry and Behavioral Science, Science 37
Christopher Reist is Medical Director, Psychiatry and Behavioral Science at Science 37, the Decentralized Clinical Trial (DCT) Operating System™, where he oversees the conceptualization and implementation of DCTs. He also serves as Chief Medical Officer for Population Health at Relias, Inc. (a Bertelsmann company), developing population health management tools. Prior to Science 37, Dr. Reist served for 17 years as Associate Dean in the School of Medicine at UC Irvine and Director of Medical Research for the Long Beach Veterans Affairs Healthcare System, managing the entire infrastructure to support a broad portfolio of basic science and clinical research.
Prior to this role, he was the Chief of Mental Health, overseeing full-service mental health care delivery to over 45,000 enrollees. From 1999 to 2018 he also served as Associate Director of the Southern California VA Mental Illness Research, Education and Clinical Center (MIRECC). Dr. Reist has extensive experience directing clinical trials. PTSD has been the focus of the recent past with trials completed in the use of cognitive enhancers to complement psychotherapy, acupuncture, use of virtual reality technology, stellate ganglion block, and medications. He chaired the External Scientific Advisory Committee for the San Diego VA Center of Excellence for Stress and Mental Health and was Co-Chair of the Government Steering Committee for the Consortium to Alleviate PTSD (VA-DoD funded $45 million grant).
Dr. Reist received his undergraduate degree in chemistry and biology from Eastern Mennonite University in Harrisonburg, Virginia. Following medical training at the Virginia Commonwealth University in Richmond, Virginia, he completed a psychiatry residency at the University of California, Irvine. He has an MBA from the Anderson School of Management at UCLA.
Message Presenter
Chris Edgar, PhD, Chief Science Officer, Cogstate
Dr. Chris Edgar is an experienced leader in cognitive assessment and clinical endpoint strategy who provides expert guidance to Cogstate’s pharmaceutical customers throughout all stages of trial conduct, from study design and test selection through final analysis. Prior to joining Cogstate, Dr. Edgar oversaw clinical endpoint strategy for multiple neuroscience indications in the Patient-Centered Outcomes Research group at Roche.
He holds a PhD in psychopharmacology from Northumbria University and has 20 years of pharmaceutical industry experience. Dr. Edgar has held other key industry positions, including Principal Scientist at Roche, Senior Clinical Lead at Bracket/UBC, and Scientific Director at Cognitive Drug Research Ltd.
Message PresenterWho Should Attend?
Executives, directors, scientists and managers from pharma, biotech and CROs responsible for the 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
Join this webinar to learn:
- Considerations for a fully-decentralized clinical trial for major depression
- Applications and use cases of remote cognitive testing in Alzheimer’s disease and other indications
- Considerations for endpoint selection and implementation for the remote context
- Validation and pilot testing of adapted conventional and computerized COAs
- Implications of FDA guidance on “Conduct of Clinical Trials of Medical Products During the COVID-19 Public Health Emergency”
Xtalks Partner
Cogstate
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.
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