Every so often, you stumble onto a marketing partnership that just seems to fit. When we were approached earlier this year about a rare disease festival happening in October, we knew immediately that we had to be a part of it. Who could pass up the opportunity to be part of a first-of-its-kind event that...
This is the ninth installment of our look at the increasingly high placebo response that is plaguing clinical trials in analgesia and psychiatry. View the other posts in the series here. Our last post reviewed several potential strategies to reduce the placebo effect, focusing on excluding high placebo responders and alternative trial designs. Today, we’ll...
For the estimated 30 million people worldwide who have Alzheimer’s disease, progress toward understanding and treating this most prevalent form of dementia is frustratingly slow. The few approved drugs address only the condition’s symptoms, though scores of drugs to prevent onset or alter the disease’s course are now under study. From high screen failure rates...
This is the eighth installment of our look at the increasingly high placebo response that is plaguing clinical trials in analgesia and psychiatry. Catch up on the rest of the series here. We’re now just over halfway through our Placebo Problem series. So far, we’ve examined the details of the rising placebo response, the mechanisms...
Premier Research is proud to be a presenting sponsor of “Disorder: A Rare Disease Film Festival,” being held in Boston in October. Festival co-founder Daniel DeFabio shares with us why having such an event is important for raising awareness, sparking conversations and hopefully, maybe even a cure or two. A couple years ago, I made...
Chances are you’ve either personally dealt with osteoarthritis (OA) or know someone who has. This common type of degenerative joint pain represents both a heavy disease burden and a major opportunity for drug developers. Read on to learn more about: OA’s prevalence Optimal diagnostic criteria for clinical trials Treatment options What OA research looks like...
We worked on a Phase II study of a drug to treat Fragile X syndrome that, like most rare work we do, was a challenge from the start. Fragile X is a rare and not fully understood genetic disorder, typically resulting from an expansion of the CGG triplet repeat within the Fragile X mental retardation 1 (FMR1) gene...
Our seventh installment of The Placebo Problem continues our look at the increasingly high placebo response that is plaguing clinical trials in analgesia and psychiatry. Check out the other posts here. The placebo response is broad. It goes far beyond the effects of merely consuming a sugar pill; it is the patient’s response to the...
Before starting Phase 1 trials, an Investigational New Drug (IND) application must be approved by the FDA. This critical early step in clinical trial development grants an exemption to laws prohibiting the transportation of drugs across state lines prior to market approval. The three major required areas of information in an IND include: Animal pharmacology...
This is the next installment of our look at the increasingly high placebo response that is plaguing clinical trials in analgesia and psychiatry. Check out the other posts here. Over the past few weeks, we’ve discussed the psychological, neurobiological, and genetic mechanisms responsible for the placebo response. Today, we turn to the study designs used...