How to Leverage eCOA for Improved Signal Detection in Pediatric & Rare Disorder Trials

Combining eSource Technology with Expert Clinical Science to Reduce Rater Errors on Cognitive, Behavioral and Developmental Assessments for Infants to Young Adults

High-quality data are critical when seeking to measure treatment outcomes, but this is especially true —and especially challenging—in rare disease trials where the stakes are high, the assessments are complex and the eligible participants are so few and far between. Missing data and non-standard data collection present considerable threats to data integrity, and when the trial sites are numerous and geographically dispersed, inter-rater variability can further compromise data quality. Electronic clinical outcome assessment (eCOA), particularly when optimized with expert clinical science input, is a proven approach to reduce missing data and enable correct and consistent assessments for a more accurate picture of treatment benefit.

In this webinar, Dr. Pamela Ventola and Mr. Jonathan Andrus will share their collective four decades of experience in developmental disabilities, pediatric neuropsychology, eClinical systems, data management and regulatory compliance to outline how clinical trial sponsors are incorporating leading-edge data capture and monitoring strategies to optimize clinical outcome assessments. Their webinar will cover how to:

• Select and adapt key outcome measures for assessing development, cognition and behavior in clinical trials of rare central nervous system (CNS) disorders
• Reduce errors through real-time capture and data monitoring using custom algorithms built directly into the eCOA tool
• Ensure successful start-up and implementation through:

                            o  Complex developmental scales such as Bayley-3

                            o Cognitive assessments such as Wechsler Scales (e.g. WPPSI-IV and WASI-II)

                            o Behavioral assessments such as BRIEF-2 and BASC-3

Dr. Ventola and Mr. Andrus will also discuss important error prevention and quality assurance enhancements including automatic scoring, flags for data quality and advanced reporting of tabulated results.

Speakers

Pamela Ventola, Senior Science Director, Pediatrics and Rare Disease, Cogstate

Dr. Pamela Ventola is Senior Science Director at Cogstate and Assistant Professor at the Yale Child Study Center. Dr. Ventola leads Cogstate’s pediatric and rare diseases portfolio, 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.

As a licensed clinical psychologist, Dr. Ventola’s primary clinical expertise is in pediatric neuropsychology, specifically developmental and genetic disorders. Her research interests involve developmental disabilities, and among her recent research is a study on brain-based mechanisms of treatment response in autism spectrum disorder (ASD). She is also utilizing eye-tracking paradigms as a novel outcome of clinical trials in ASD and is involved in studies on novel pharmacological therapeutics in individuals with ASD.

Dr. Ventola received her Doctor of Philosophy in Clinical Psychology from the University of Connecticut and completed her clinical training and Postdoctoral Fellowship at the Yale University School of Medicine, Child Study Center. She serves on the editorial review board of multiple academic journals. Specifically, she serves as a reviewer for the Journal of Autism and Developmental Disorders, Journal of the American Academy of Child and Adolescent Psychiatry, Clinical Psychology Review and the Autism International Journal of Research and Practice. Dr. Ventola has authored numerous peer-reviewed manuscripts, book chapters and scientific presentations.

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Jonathan Andrus, Chief Business Officer, Clinical Ink

As Chief Business Officer, Jonathan Andrus leads Clinical Ink’s global data management and quality & compliance teams to help drug sponsors better leverage eSource data. With 20+ years of experience, Mr. Andrus brings extensive expertise developing eClinical services which integrate data and technology to help life science companies optimize study execution.

Mr. Andrus joined Clinical Ink from Bioclinica where he led the eClinical Solutions Group to develop their current service offerings, including data management, quality management, implementation services and interactive web response system (IWRS). While at Bioclinica, Mr. Andrus built relationships and forged strategic partnerships with sponsors, contract research organizations (CROs), regulatory bodies, technology developers and clinical research professionals. Prior to BioClinica, Mr. Andrus worked in pharmaceutical consulting and with CROs focused on quality, data management and validation.

An active thought leader, blogger and presenter, Mr. Andrus served as chair of the Society for Clinical Data Management (SCDM) in 2008 and 2014 and currently serves as the society’s Treasurer. He is also an active member of DIA, ASQ, ACRO and CDISC. He earned his bachelor’s and master’s degrees from Temple University’s College of Liberal Arts and Graduate School of Pharmacy and is a Certified Quality Auditor (CQA) and Certified Clinical Data Manager (CCDM®).

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