Unraveling the field’s complexity requires an understanding that comes only with experience. We’ve conducted more than 350 neuroscience projects across all phases of development in the past five years, many of which focused in rare disease and pediatric populations. Our experienced team of experts have acquired a notable history of breakthrough work, including the first...
February 21-23, 2024 Washington, DC Join Premier Research at the ISCTM conference in Washington, DC. The International Society for CNS Clinical Trials and Methodology (ISCTM) is a prominent organization dedicated to advancing clinical research methods in CNS therapeutics. We invite you to connect with us during the conference. If you are interested in exploring potential...
Introduction 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 sites where patients were already being diagnosed and treated. To achieve this, the Premier...
The worldwide prevalence and burden of central nervous system (CNS) disease is high and increasing, in part due to the aging of the global population. In the US, at least 5.5 million people have been diagnosed with Alzheimer’s disease, approximately 1 million live with Parkinson’s disease, and roughly 40 million cope with anxiety disorders. Despite...
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,...
The landscape for Alzheimer’s disease diagnosis has changed significantly over the past decade, but there is still only one conditionally FDA-approved medication. Despite extensive research and many expensive clinical trials, more than 200 investigational programs have failed or been abandoned in the past 10 years alone. New treatments are needed to prevent Alzheimer’s, delay its...
With billions of neurons, the brain is the most complex organ in the body, so it’s not surprising that neuroscience clinical trials—more so than trials in other medical specialties—face major challenges. Despite volume of research and funding, neuroscience clinical trials continue to fail for many reasons. Among them, lack of reliable biomarkers, subjective outcome parameters,...
Meet Our Speakers: Andreas Schreiner, M.D.Senior Vice President, Medical Affairs, Neuroscience and Analgesia Adam SimmonsExecutive Director, Program Strategy, Neuroscience
July 20th, 202311:00 a.m. EDT With billions of neurons, the brain is the most complex organ in the body, so it’s not surprising that neuroscience clinical trials—more so than trials in other medical specialties—face major challenges. Despite volume of research and funding, neuroscience clinical trials continue to fail for many reasons. Among them, lack of...