Tag: Neuroscience

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...

Medical and Regulatory Affairs

The Ongoing Quest for Evidence on the Health Effects of Cannabis and Cannabis-Derived Products

Inadequate funding and burdensome regulatory barriers in the United States are two challenges that must be tackled if clinical researchers are to answer important public health questions about the pros and cons of cannabis and cannabinoid use, one of the world’s leading scientific bodies has concluded. These are among nearly 100 conclusions and recommendations reached...

Medical and Regulatory Affairs

State of the Nation: Cannabis-Based Therapies

On June 25, 2018, the U.S. Food and Drug Administration (FDA) approved Epidiolex (cannabidiol, or CBD) oral solution for the treatment of seizures associated with two rare and severe forms of epilepsy, Lennox-Gastaut syndrome and Dravet syndrome. In addition to ushering in the first-ever approved drug for Dravet syndrome, the greenlighting of Epidiolex marks the...

STARR 911: Understanding & Implementing the New Guidance at Your Site

Premier Research recently contributed to the STARR 911 initiative, a project of the STARR Coalition to provide actionable guidance for clinical researchers after identifying volunteers with suicidal leanings. This post provides more information on the process itself, which was presented earlier this year at the 2018 ASCP Annual Meeting in Miami. Background The primary goal...

STARR 911 Provides Clinical Researchers With Actionable Guidance for At-Risk Volunteers

Having a chronic condition increases the odds of suicide by 363%, and patients with mental illness are particularly at risk.[1] For individuals contacting sites about possible enrollment in a clinical trial, the call may be their first attempt to reach out for help – yet many do not receive the education and support that could...

Consulting

Nostalgia or Shell Shock? Assessing PTSD Is a Challenge by Any Name

Nostalgia. Irritable heart. Shell shock. No, this isn’t a word-association game. These are among the many terms applied over the years to the highly amorphous condition we now call post-traumatic stress disorder. While people have experienced shocking, scary, and dangerous events since the dawn of mankind, the study of the cause and treatment of PTSD...

Clinical Research: Phase 1 - Phase 4

Where Expertise Meets Nuance: Conducting PTSD Clinical Trials

The invisible wounds caused by post-traumatic stress disorder can dramatically affect mental health and diminish quality of life. According to the Sidran Institute, a nonprofit organization serving people who have experienced or witnessed traumatic events, PTSD is associated with an extremely high rate of medical and mental health service use. Patients may incur the highest per-capita cost...

Clinical Research: Phase 1 - Phase 4

Six Ways to Help Manage Staff Trauma Exposure in PTSD Trials

There are currently more than 300 ongoing clinical research studies, mostly in the academic arena, occurring around the world into post-traumatic stress disorder (PTSD) in various populations. But those with PTSD may not be the only ones’ suffering. The members of the research teams trying to help those with trauma illnesses, like PTSD, need to...

Clinical Research: Phase 1 - Phase 4

Better Days Ahead? The Emerging State of CNS Drug Development

Experts describing recent advances in drug development often drift into hyperbole — but really, can you blame them? Gene therapies and drugs that weaponize the immune system against tumor cells are among recent breakthroughs that were unthinkable even a decade ago. But therapies for central nervous system disorders have been a stubborn exception. “We recognize...

Patient and Stakeholder Engagement

AD Trials: Three routes to increasing enrollment

Since the mid-1990s, researchers have struggled to enroll sufficient numbers of patients in their trials for Alzheimer’s disease (AD) therapies. As a result, few new therapies have actually come to market—which is tragic for the 47 million people currently living with the disease. Three key strategies, executed in concert, may help overcome recruitment issues in...