Neuroscience clinical trials, especially those for psychiatry and analgesia indications, have always had to deal with the challenge of high placebo response. Most troubling is that the placebo response rate seems to be on the rise, at least in the U.S. Bigger placebo responses make it harder to show that an experimental treatment is...
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...
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...
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...
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...
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...
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...
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...
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...
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...