Clinical Research: Phase 1 - Phase 4

Navigating the FDA’s Draft Guidance on Psychedelic Drug Development

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...

Clinical Research: Phase 1 - Phase 4

Leveraging Technology and Expert Clinician Review to Enhance Risk Detection in Neuroscience Studies

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,...

Quality

Operational Challenges of Neuroscience Clinical Trials, Part 4: Assessment Subjectivity

In this blog series, we’ve been discussing some of the challenges of conducting clinical trials in neuroscience. In our final post of the series, we turn to another major one: ensuring that assessments are conducted with high quality whilst also minimizing subjectivity. Rating subjectivity can make signal detection substantially more difficult, if not impossible. This...

Clinical Research: Phase 1 - Phase 4

Operational Challenges of Neuroscience Clinical Trials, Part 1: Overview

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, both conceptual and practical. In this new blog series, we’ll look at the challenges sponsors face when operationalizing clinical trials and share lessons from...

Patient and Stakeholder Engagement

7 Ways to Engage Military Vets in PTSD Clinical Trials

Combat related trauma is significantly affecting U.S. military veterans compared to other military populations across the globe. As many as 20 percent of the U.S. military veterans who served in Iraq and Afghanistan and up to 30 percent of those who fought in the Vietnam War will suffer from Post-Traumatic Stress Disorder (PTSD) in a...

Premier Research Strategist to Discuss Evolving Site Landscape at CNS Summit

DURHAM, N.C., October 26, 2016 — Premier Research’s lead strategist will participate in a panel discussion on the evolving landscape for investigator sites at CNS Summit 2016 in Boca Raton, Florida. Krista Armstrong, Vice President of Strategic Development, will join colleagues in addressing topics such as: Advantages and disadvantages of site consolidation Site selection and strategic...

Premier Research Expands Staffing Amid Growing Demand for Neuroscience Studies

DURHAM, N.C., May 23, 2016 — As demand for neuroscience clinical trials grows, Premier Research has named neuroscience expert Dr. Susan Kozauer Senior Medical Director for Psychiatry. Kozauer joins recent hires Anne Marie Nagy, Ph.D., Dr. Teresa Nunes, Dr. Carol Gaines, and Todd Leathers on a team that has performed almost 400 neurology and psychiatry...

Medical Director Authors Novel Look at Kleefstra Syndrome

DURHAM, N.C., April 1, 2016 — A paper authored by a Premier Research medical director takes an unprecedented look at motor function and behavior in adults and children with Kleefstra syndrome. Susanne Schmidt, M.D., Ph.D., and four Norwegian colleagues published their findings in the European Journal of Medical Genetics. The study of four male and...