Qualitative exit interviews are emerging as a valuable addition to clinical trials for central nervous system (CNS) disorders like schizophrenia, offering crucial insights into patient and caregiver experiences for sponsors, regulators, and others involved in the development, approval, and commercialization...
Expertise: Neuroscience 40 results
Neuroscience
Jessica Hughes
Approximately 350 million people around the world live with major depressive disorder (MDD). While there are existing treatments, up to two-thirds of patients with MDD do not achieve remission following an initial adequate trial of antidepressant medications and nearly 70%...
When approached for an early-in-illness schizophrenia trial, Premier Research knew that patient recruitment would be challenging and require creative approaches for success. Based on our experience in mental illness studies and with this indication, we recognized the importance of identifying...
The FDA’s Center for Drug Evaluation and Research issued a structured, meticulous roadmap to advance the clinical development of psychedelic drugs, highlighting key considerations in regulatory frameworks, ethical conduct, chemistry manufacturing controls (CMC), and clinical studies to ensure safety and...
Across all indications, the primary source of trial failure has been—and remains—an inability to demonstrate efficacy.1 An analysis of 640 phase 3 trials with novel therapeutics demonstrated that 54% failed in clinical development. Among those that failed, more than half—57%—failed...