CNS Safety of Drugs in Late Phase Clinical Trials: Using Cognitive Information in Discussions with Regulators, Upcoming Webinar Hosted by Xtalks
In this free webinar, learn how to consider the use of cognitive tests to understand the central nervous system (CNS) safety of new drugs. Attendees will learn how consideration of drug-related cognitive decline differs for treated groups or individual subjects. The featured speaker will discuss how to ensure the study designs for the measurement of cognition are optimized to provide appropriate information to scientific and regulatory bodies.
TORONTO, March 9, 2022 /PRNewswire-PRWeb/ -- In clinical trials of new drugs that have direct or indirect effects on the central nervous system (CNS), regulatory and medical/scientific groups must be confident that application of the drug at its established clinical dose is not associated with negative effects on brain function. Cognition is one important marker of CNS function. In late phase clinical trials, the nature and magnitude of changes in cognition can provide an accurate index of negative CNS effects of the new drugs being studied.
While information about the effects on cognition are used commonly to guide drug development in early phase studies, in late phase clinical trials the design and execution of cognitive tests, and the analyses of the data arising, are constrained by different factors. These factors can include greater heterogeneity in sample characteristics, less precision in assessment contexts, less time available for assessments and the necessity for regulatory compliance. In addition to this data in late phase clinical trials where there is concern about CNS safety, submission to data safety monitoring boards may also be required.
In this webinar, featured speaker, Paul Maruff, PhD, Chief Innovation Officer, Cogstate, will review the aspects of outcomes considered important to regulators from Cogstate's recent experience in late phase clinical trial programs investigating: Esketamine in adults with major depressive disorder; Evolocumab in children with familial hypercholesterolemia; and Lurasidone in adolescents with schizophrenia.
Join the live webinar on Wednesday, March 30, 2022, at 1pm EDT.
For more information, or to register for this event, visit CNS Safety of Drugs in Late Phase Clinical Trials: Using Cognitive Information in Discussions with Regulators.
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