Clinical trials in patients with developmental and epileptic encephalopathy (DEE) present considerable challenges for research teams, including the difficulty in identifying patients, the large geographic spread of patients and the need for measurements that can catch even the smallest degree of change in behavior or function.
One byproduct of these challenges is the difficulty that arises in site selection. It becomes a near impossible task to find sites that are in the appropriate geographies and have the level of expertise to administer the scales necessary for signal detection.
In this webinar, the expert speaker will address these obstacles and share solutions. She will describe approaches to collect data across large geographic areas and in locations that do not have specialized or experienced raters. She will share factors to consider when selecting cognitive and behavioral endpoints for DEE trials, including perspectives from regulatory agencies.
Moreover, she will describe the application of developmental assessments (e.g., Bayley-4) and behavioral scales (e.g., the Vineland-3), along with approaches for determining minimally clinically important difference (MCID) with these measures in DEE populations.
Register for this webinar to gain insights into the complex challenges of conducting clinical trials for developmental and epileptic encephalopathy.
Speaker
Pamela Ventola, PhD, Chief Science Officer, Cogstate
Dr. Pamela Ventola is Chief Science Officer at Cogstate, an Associate Professor at the Yale Child Study Center and a licensed Clinical Neuropsychologist. Dr. Ventola leads Cogstate’s science team 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.
Dr. Ventola received her PhD in Clinical Psychology from the University of Connecticut and completed her clinical training and Postdoctoral Fellowship at the Yale University School of Medicine. She serves on the editorial review board of multiple academic journals and has authored numerous peer-reviewed manuscripts, book chapters and scientific presentations.
Message PresenterWho Should Attend?
This webinar will appeal to Executives, Directors, Scientists and Managers from pharma, biotech and CROs responsible for clinical development of clinical trial solutions in rare disease studies, 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
Attendees will learn about:
- Approaches for data collection across large geographic areas
- Factors to consider when selecting cognitive and behavioral endpoints
- Approaches for determining minimally clinically important difference
Xtalks Partner
Cogstate
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 www.cogstate.com.
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