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...
There is a significant unmet need for medications for addictions, chronic, relapsing disorders that lead to biological and behavioral changes that can have harmful medical and psychological consequences. Addictions are common, debilitating and costly disorders resulting in more than $740 billion a year in increased healthcare costs, crime, and lost productivity. Multiple medications have been...
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...
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...
The use of Clinical Endpoint Committees for centralized adjudication of efficacy and/or safety endpoints can help to standardize outcomes and optimize the quality of clinical trial data, driving study success. Some compounds and many devices face the challenge of defining efficacy or safety endpoints so that they are scientifically measurable, objective, and valid. Often, clinical...
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...
A trial’s success depends largely on the ability to recruit and retain an adequate number of participants. Recruitment can be especially difficult in opioid clinical trials, due to a variety of factors. Here are seven things you should know about the challenges associated with recruiting patients for opioid trials: 1. Certain necessary aspects of trial...