CNS Trials Are Difficult — Do They Have To Be?

By Francesco Bibbiani, MD, CPI, Vice President and Therapeutic Area Head, and Marty Kraut, Ph.D., PMP, Director of Operations, CNS Center of Excellence

The central nervous system (CNS) clinical trial landscape is complex and challenging. CNS indications, which include mood disorders, neurodevelopmental and neurodegenerative diseases, and chronic pain, are the leading cause of illness and disability worldwide. However, despite their great unmet need, these trials have a difficult time reaching approval. Their endpoints are often subjective due to their reliance on clinician-, caregiver-, or patient-reported scales and questionnaires which can differ widely across sites and raters. Patient selection is also complex due to the overlap in symptomatology for psychiatric conditions.

To better support CNS trials, Avance Clinical launched the CNS Center of Excellence (CoE), which aims to help sponsors design and execute more effective CNS studies. Avance Clinical’s CoE integrates expert perspectives across neurobiology, toxicology, biostatistics, regulatory affairs, clinical development, and operations to provide end-to-end trial guidance. Download the full article to explore how the CNS CoE can help sponsors mitigate CNS-specific risks and streamline their route to approval.