Premier Perspectives Blog

Insider Insights in Clinical Development

We were conducting a trial for a painful diabetic neuropathy (PDN) drug and were investigating why one site had an especially high placebo response rate. Then one of our representatives, waiting in the site’s lobby to meet with the principal investigator, pinpointed the likely reason when a patient walked in the door. “Mrs. Jones,” theRead more

Between 7 and 10 percent of the U.S. population suffers from some type of neuropathic pain, and a significant share of those affected require chronic pain treatment.[1] This high rate of occurrence makes our limited understanding of these afflictions, and the long search for effective treatments, all the more frustrating. Treating neuropathic pain starts withRead more

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, examine experimental trial designs, inclusion and exclusion criteria, and other approaches to managing the placebo effect.Read more

 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 theRead more

The placebo response is a real psychological, physiological, and ultimately statistical phenomenon that can be a powerful therapeutic tool in the world of medicine, especially when it comes to chronic pain conditions. For a drug to be approved, its developers must be able to demonstrate that it is significantly more effective compared to a placebo.Read more

This is the fifteenth and final installment of our look at the increasingly high placebo response that is plaguing clinical trials in analgesia and psychiatry. Read the rest of the posts in the series here. As our Placebo Problem series draws to a close, we conclude by taking a brief look at three ethical issuesRead more

This is the fourteenth installment of our look at the increasingly high placebo response that is plaguing clinical trials in analgesia and psychiatry. Read the rest of the posts in the series here. The term “placebo” first took hold in an unlikely place: funerals. Placebo, Latin for “I shall please” first came into use inRead more

This is the thirteenth installment of our look at the increasingly high placebo response that is plaguing clinical trials in analgesia and psychiatry. Read the rest of the posts in the series here. Until now, our Placebo Problem series has focused exclusively on the placebo response in adults. Today we turn to another population: kids.Read more

This is the twelfth 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 posts in the series here. After focusing exclusively on the placebo effect in this series, today we’re going to take a quick detour, turning toRead more

This is the eleventh installment of our look at the increasingly high placebo response that is plaguing clinical trials in analgesia and psychiatry. Read the rest of the posts in the series here. As we discussed last week, there are so many trial-related details that can influence the magnitude of the placebo response. But thereRead more

This is the tenth installment of our look at the increasingly high placebo response that is plaguing clinical trials in analgesia and psychiatry. Catch up on the other posts in the series here. Over the last two weeks we’ve discussed several specific strategies to reduce the placebo response. One effort that is becoming increasingly popularRead more

There is a great deal of variability when it comes to osteoarthritis (OA) clinical trial designs. From the type of drug being studied to the regulatory approach of the target market to the optimal route of administration, assessment selections must be carefully tailored to meet the unique needs of each individual trial. 1. Pick theRead more

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