Neuroscience
Expertise: Neuroscience 28 results
Neuroscience
ISCTM
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 efficacy in addressing psychiatric and substance use disorders. In this blog, Premier Research dissects the…
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 due to inadequate efficacy.2 In neuroscience indications, an estimated 85% of late phase studies fail,…
Neuroscience
Fabiana Da Silva Alves, Ph.D.
Neuroscience
Andreas Schreiner, M.D.
Clinical research into neurological diseases is often hindered by a myriad of patient related problems. What can be done to overcome these issues and improve the efficacy of neuroscience trials? In the wake of the pandemic, new opportunities and challenges for neuroscience clinical trials are emerging. After years of slow progress, mental health is now…