Clinical Trials of Schizophrenia: Optimizing Patient Reported Outcomes and Performance Outcome Assessments

The majority of clinical outcome assessments (COAs) in schizophrenia trials are clinician reported outcome (ClinRO) assessments such as the PANSS and various forms of CGI and functional instruments which use information from clinical interviews with the patient and perhaps a caregiver. These COAs provide critical insights into clinical status, making use of the expertise and insight of psychiatrists and other healthcare professionals.

However, there is growing recognition from regulatory agencies that data reported directly from patients, without interpretation from clinicians and other people, provide critical information regarding quality of life, cognitive function, treatment benefits and satisfaction.  Thus, supplementing these assessments with other COA types, including Patient Reported Outcome (PRO) assessments and Performance Outcome (PerfO) assessments, may add valuable outcomes to enable better decision making in clinical trials.

Register for this webinar to hear presenters discuss the use of PROs and PerfOs to measure meaningful aspects of health in schizophrenia. The integration of such measures into clinical trials, including the use of eCOA, will also be addressed.

Speakers

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 Principle Scientist at Roche, Senior Clinical Lead at Bracket/UBC, and Scientific Director at Cognitive Drug Research Ltd.

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Jenny Ly, PhD, Senior Clinical Science Advisor, ERT

Jenny Ly is currently a Senior Clinical Science Advisor at ERT. She is clinical psychologist with a specialization in neuropsychology and has over 10 years of experience in the design and management of clinical research. Dr. Ly has extensive experience consulting on best practices for electronic clinical outcome assessments (eCOA) design and implementation as well as optimizing data quality through training for site raters, patients, and caregivers. She is proficient in assessing and working with patients with neurologic and psychiatric disorders. She authored over 15 manuscripts and taught statistical methods courses. She obtained her Ph.D. in Clinical Psychology from The Graduate Center-City University of New York and B.A. from Wellesley College.

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