Opioid analgesics are essential to the management of pain in many patients, but they are also associated with potential risks for abuse, overdose, and diversion, concerns which must be considered in the planning and execution of clinical trials studying these controlled substances. In this paper, we discuss the challenges of conducting clinical trials of controlled...
This is the fifth installment of our look at placebo response issues in analgesia and psychiatry clinical trials. Read other posts in the series here. Studies examining genetic variants associated with high or low placebo responses – the “placebome” – are relatively recent, but represent an important line of research that can yield insights into...
Acne is a common, complex skin disorder most people experience at some point in their lives. While many treatments are currently available, options for severe acne are limited. Additionally, clinicians are aiming to reduce long-term broad-spectrum antibiotic use, which is becoming less effective as antibiotic resistance becomes more common. Possible solutions? More effective topical treatments and targeted therapies. Here...
DURHAM, N.C., September 5, 2017 — Defining efficacy and safety endpoints that are scientifically measurable, objective, and valid is a critical challenge for developers of medical devices. At a live webinar on Tuesday, September 12 (11am EDT / 4pm BST / 5pm CEST), Premier Research will examine how clinical endpoint committees play an ever-larger role...
DURHAM, N.C., SEPTEMBER 5, 2017 — Sponsors and CROs can forge stronger relationships by pursuing long-term partnerships that value collaboration over transactions. Premier Research’s top neuroscientist will discuss how when she hosts a session at Outsourcing Clinical Trials New England in Boston. Krista Armstrong, Vice President and Head of Neuroscience, will describe best practices for...
This is the fourth in our series examining the increasingly high placebo response issues plaguing analgesia and psychiatry clinical trials. Additional posts in the series are located here. As with many other aspects of placebo research, the majority of research on underlying neurobiological mechanisms has focused on placebo analgesia. In fact, roughly 40 positron emission...
There are many pitfalls that come with preparing an Investigational New Drug application for FDA submission. Luckily, there are also plenty of ways to avoid them. But the most important strategy? It all comes down to one thing: Always remember to keep your audience (the FDA reviewers) in mind as you write. These five actionable...
This is the third installment of our look at the increasingly high placebo response that is plaguing clinical trials in analgesia and psychiatry. Additional posts in the series can be accessed here. Solutions to the placebo problem require an understanding of the underlying mechanisms. Broadly, research on contributors to the placebo response falls into two...
When you’re looking into conducting a natural history study, you’ve got two things to consider up front: the premise that underlies all of these studies, and which of several types suits your purpose. We tackled these and other topics in our last rare disease webinar. Natural History vs. Registry Studies in Rare Disease considers a...
This is Part Two of our series on the increasingly high placebo response that is plaguing clinical trials in analgesia and psychiatry. Read the other parts here. Analgesic and psychiatric drug development is facing an enormous problem: rising placebo responses in randomized controlled trials (RCTs) threaten the ability of pharmaceutical companies to successfully identify novel...