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...
Most early-stage biotechnology companies have limited resources and manpower. As a result, early-stage biotechs conducting randomized clinical trial research often need a CRO’s help to deliver the quality data required to make their ideas and theories achieve practical purpose. In addition, engaging a CRO with a depth of strategic expertise early in the planning process...
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...
Measuring, interpreting, and mitigating placebo response is a persistent and growing challenge in analgesia clinical trials. In the conclusion of our Premier Voices podcast series on the placebo problem, Paul Mirek, Marketing Manager, and Michael Kuss, BS, Vice President, Analgesia Product Development, examine experimental trial designs, inclusion and exclusion criteria, and other approaches to managing the...
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...
According to a Council of Foreign Relations report, ensuring a safe and secure healthcare marketplace that can provide innovative therapies is no longer an undertaking for a single nation. The report concludes there is no way a single government regulator, including the gold-standard U.S. Food and Drug Administration (FDA), can support innovation and regulate products...
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...
In May 2012, the leaders of 30 medicine regulatory bodies from around the world gathered at the 65th World Health Assembly in Geneva, collectively puzzling over how to improve cooperation among them. Their answer came later that year: form the International Coalition of Medicines Regulatory Authorities (ICMRA), a voluntary group of Heads of Agency (HoA)...
The placebo effect’s impact on drug development is widely known, but you may be surprised to learn that the word “placebo” has had multiple meanings — all of them pejorative — going back hundreds of years. Scott Millard, Premier Research’s Executive Director for Strategic Development and Analgesia, explores the role of placebos in the...
The primary purpose of early-stage clinical trials is to determine the recommended dose and toxicity profile of an investigational drug or multi-drug combination therapy. Since molecularly targeted agents (MTAs) and immunotherapies have toxicities that are distinct from cytotoxic chemotherapies, traditional dose escalation methods using toxicity-based endpoints may not be suitable for phase I studies of...