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...
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...
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...
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...
For hundreds of years, the medical community has known that the mere act of receiving treatment, even if it’s just a sugar pill, can improve a patient’s symptoms. Therefore, in order to ensure that the effects of an experimental treatment are real, most randomized controlled trials (RCTs) include a placebo arm. Placebos are most often...
When it comes to pediatric analgesic clinical trials, protocols cannot be simply “cut and paste” from adult trials. Likewise, extrapolation of efficacy and risks from adult studies is not always reliable due to developmental and physiological differences. Researchers engaged in pediatric trial design must consider the specific physiology, pharmacology, and normal daily activities for each group being...
The journey to treating fibromyalgia has taken a sometimes circuitous path. After a burst of activity about a decade ago, the pursuit of new therapies took a years-long pause before reigniting in recent years. In the past five years, we’ve performed 16 fibromyalgia clinical trials (more than any other CRO), and here are some reflections...
In the early days of fibromyalgia drug research, trial site selection centered almost exclusively on rheumatologists and pain centers. But with more drugs on the market and still more studies underway, there has been significant expansion in the number of sites equipped to conduct this research. Up to a point, anyway. As fibromyalgia therapy matures,...
Placebo response is an ever-present threat in analgesia clinical trials, and failure to sufficiently prove the efficacy of the researched compound can easily doom your promising new product. The risk can be especially pronounced when studying drugs to treat fibromyalgia. Fibromyalgia patients can be — and don’t use the term casually or critically — needy....
Patients in fibromyalgia clinical trials are an interesting bunch. On one hand, you’ll seldom find a more accommodating and cooperative group of people. For years the condition was so poorly understood that many patients were treated dismissively by physicians who didn’t recognize fibromyalgia as a genuine affliction. And even today, the disease’s many symptoms continue...