CNS Safety of Drugs in Late Phase Clinical Trials: Using Cognitive Information in Discussions with Regulators

Life Sciences, Clinical Trials, Pharmaceutical, Drug Safety,
  • Wednesday, March 30, 2022

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, it may also be required to submit to data safety monitoring boards.

In this webinar, the featured speaker Dr. Paul Maruff 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
  • Lurasidone in adolescents with schizophrenia


Paul Maruff_Cogstate

Paul Maruff, PhD, Chief Innovation Officer, Cogstate

Professor Paul Maruff is one of the founders of Cogstate and served as Chief Science Officer before taking on the role of Chief Innovation Officer. He is a neuropsychologist with expertise in the identification and measurement of subtle behavioral and cognitive dysfunction. Paul’s research integrates conventional and computerized neuropsychological testing with cognitive neuroscientific methods to guide decision making in drug development and in clinical medicine. Paul remains an active researcher. He is appointed Professor at the Florey Institute for Neuroscience and Mental Health. He is currently clinical co-chair of the Australian Imaging Biomakers and Lifestyle (AIBL) study. Paul has published over 450 research articles in international peer-reviewed scientific journals and has co-authored 15 book chapters.

Message Presenter

Who 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

Register for this webinar to learn:

  • How to consider the use of cognitive tests to understand the CNS safety of new drugs
  • How consideration of drug-related cognitive decline differs for treated groups or individual subjects
  • How ensuring study designs for the measurement of cognition can be optimized to provide appropriate information to scientific and regulatory bodies

Xtalks Partner


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

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