Applying Advanced Analytics to Overcome CNS Trial Challenges

Although the clinical research community invests substantial capital into developing new treatments for central nervous system (CNS) diseases, success remains very elusive, with 85%-99% of clinical trials failing to result in approval for new treatments. Reasons for the relatively low success rates are manyfold, but research in most CNS indications shares overlapping challenges, such as the subjective nature of clinician-reported outcome assessments on which many CNS endpoints are based, increasing placebo response, eligibility criteria, and burdensome requirements on sites or patients.

The increasing digitalization of research processes, and the resultant proliferation in electronic data generated, present new opportunities for research teams.

In this webinar, Signant’s clinical experts and guest panelists discuss data analytics approaches to improving CNS trial outcomes. Register for this topical virtual event to learn how clinical and data science teams can collaborate to monitor and proactively manage endpoint data quality throughout a trial.

Featured topics will include:

• Managing data quality at sites
• Using artificial intelligence to identify at-risk raters
• Identifying appropriate, reliable participants in schizophrenia and early Alzheimer’s disease trials based on instrument data

Don’t miss this opportunity to hear from multidisciplinary experts about the role of data analytics on present and future CNS research.

Speakers

Alan Kott, MUDr., Practice Leader, Data Analytics, Signant Health

Dr. Kott is a Practice Leader for Data Analytics at Signant Health. He has both academic and industry experience in clinical trials. Having led the development of the Data Analytics Program for Signant, he has overseen the design and implementation of data analytics across all Signant supported clinical trials. Prior to Signant Health, Dr. Kott worked as an Assistant Professor at Charles University, 1st Medical Faculty – Department of Psychiatry and a house officer in Psychiatry at General Teaching Hospital, Department of Psychiatry, both in Prague, Czech Republic. Dr. Kott has a Medicinae Universae Doctor (MUDr.) from Charles University.

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John Harrison, PhD, Principal Consultant, Metis Cognition Ltd.

Professor John Harrison is an expert psychologist with a special interest in cognition. John is Principal Consultant at Metis Cognition, a psychology practice established to advise with the selection and successful integration of cognitive testing into therapeutic development programs. He is also an Associate Professor with the AUmc Alzheimer Center and Visiting Professor at King’s College London. He holds Chartered Psychologist status and has authored/co-authored more than 80 books and scientific articles, including a popular neuroscience book ‘Synaesthesia: The Strangest Thing’.

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Colin Sauder, PhD, Director, Clinical Scientist, Karuna Therapeutics

Colin Sauder, Ph.D. is a director and clinical scientist at Karuna Therapeutics. He has both academic and industry experience in clinical trial design, utilization of novel biomarkers as endpoints, and the use of data analytics to mitigate risk and improve trial outcomes. At Karuna Therapeutics, Colin oversees the implementation of eCOA for multiple Phase 3 programs, including the integration of eCOA data in blinded review processes for ongoing studies. He previously oversaw clinical assessment at a large CNS-focused clinical trials site and has worked with multiple eCOA vendors as both a site rater and clinical scientist. Colin received his Ph.D. in clinical psychology from Stony Brook University and is a licensed psychologist.

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