As the COVID-19 pandemic spread, research teams worldwide quickly adapted study plans to safely continue research whenever possible. While some observational studies were put on hold entirely, other therapeutic trials were continued with many or all study activities occurring remotely. In some cases, clinical sites were able to remain open with temperature checks, hand washing and social distancing. Where feasible, remote administration of clinical outcomes assessments (COAs) was implemented in order to minimize the loss of data.
What were momentary adaptations have led many clinical trial teams to look longer-term at remote administration options and consider the value of virtual, decentralized, or direct-to-patient clinical trial study designs. Indeed, the use of remote administration solutions for COAs is likely only going to increase. Understanding the nuances behind these methods of data collection is vital in the future of clinical research.
In speaking with sponsors, license holders, technology partners and IRBs, our team has gained many perspectives and will share insights into successful implementation of remote COA administration for both computerized and traditional assessments. In this webinar, the speakers will outline important lessons learned to help guide participants’ teams through remote assessment solutions, as well as specific adaptation options for computerized and conventional assessments.
Chris Edgar, PhD, Senior Vice President, Clinical Science, Cogstate
Dr. Chris Edgar has an extensive background in the application of clinical outcome assessments (COAs) in drug development and has worked in the pharmaceutical industry for the past 17 years. He is the former scientific director of Cognitive Drug Research Ltd., the developers of CDR System, one of the earliest computerized cognitive test systems to be widely employed in clinical trials. Edgar also has a background in COA management and rater training delivery with Bracket/UBC, and CNS/neuroscience clinical trial design and outcomes research with SHGVP and as an independent consultant. Edgar is a psychologist with expertise in clinical trials methodology, COA implementation and related regulatory science topics. Edgar’s research seeks to carefully define and apply clinical endpoints to answer key questions throughout the clinical development plan and product lifecycle. Edgar has published over 20 research articles in international peer-reviewed scientific journals.Message Presenter
Paul Maruff, PhD, Chief Science Officer, Cogstate
Professor Paul Maruff is one of Cogstate’s founders. He is a neuropsychologist with expertise in the identification and measurement of subtle behavioral and cognitive dysfunction. Maruff’s research integrates conventional and computerized neuropsychological testing with cognitive neuroscientific methods to guide decision-making in drug development and clinical medicine. He has worked extensively on methods to identify subtle neurocognitive impairment and assess the efficacy of pharmacological treatment in AD, mild cognitive impairment and the HIV dementia complex. He has extended this approach to identify cognitive dysfunction and monitor treatment efficacy in psychiatric diseases such as schizophrenia, obsessive-compulsive disorder and depression in adults, as well as attention deficit disorder, developmental dyspraxia and substance abuse in children. Maruff is an active researcher, appointed professor at the Florey Institute for Neuroscience and Mental Health. He is currently clinical co-chair of the Australian Imaging Biomarkers and Lifestyle (AIBL) study. Maruff has published over 250 research articles in international peer-reviewed scientific journals and has co-authored 10 book chapters.Message Presenter
Eric Siemers, MD, Distinguished Medical Adviser, Cogstate
Dr. Eric Siemers is the Distinguished Medical Adviser at Cogstate. His experience in clinical trials of neurodegenerative disease spans over 25 years, with a research focus on the use of biomarkers in investigational drug research, the development of trial designs that fully characterize the effects of investigational drugs on chronic diseases, and more specifically, the development of strategies for treating individuals before the onset of symptoms of neurodegenerative diseases. Prior to Cogstate, Dr. Siemers served as Distinguished Medical Fellow for Eli Lilly and Company’s Alzheimer’s Disease Global Development Team. Previously, Dr. Siemers founded and headed the Indiana University Movement Disorder Clinic; his research there included investigations of Parkinson’s disease and Huntington’s disease, and he established one of the first centers for surgical PD treatments in the US. Dr. Siemers earned his MD from the Indiana University School of Medicine.Message Presenter
Pamela Ventola, PhD, Senior Science Director, Pediatrics and Rare Disease, Cogstate
Dr. Pam Ventola leads Cogstate’s Rare Disease and Pediatric Center for Excellence, providing Cogstate customers with strategic oversight and expert guidance throughout all stages of their study planning and execution – from endpoint selection, rater training and strategic monitoring to final statistical analysis. She is also an Assistant 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. Dr. Ventola received her Doctor of Philosophy in Clinical Psychology from University of Connecticut and completed her clinical training and Postdoctoral Fellowship at the Yale University School of Medicine, Child Study Center. Dr. Ventola has authored numerous peer-reviewed manuscripts, book chapters and scientific presentations.Message Presenter
Who Should Attend?
Executives, directors, scientists and managers from pharma, biotech and CROs responsible for the clinical development of CNS or rare disease therapeutics, 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
Participants will learn…
- General principles that guide effective remote administration of COAs
- Important considerations to help your team successfully navigate remote assessment implementation
- Adaptation options for conventional and computerized COAs
- Examples of how sponsors, IRBs and regulatory agencies are adapting to remote assessment realities
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.