Premier Perspectives Blog

Insider Insights in Clinical Development

Combat related trauma is significantly affecting U.S. military veterans compared to other military populations across the globe. As many as 20 percent of the U.S. military veterans who served in Iraq and Afghanistan and up to 30 percent of those who fought in the Vietnam War will suffer from Post-Traumatic Stress Disorder (PTSD) in aRead 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

Even when things go pretty well, launching a clinical trial is a game of long odds. And when the deck is stacked against you the way it was when we set out to study a drug for sickle cell disease, the difficulties can add up fast. So even we were surprised by the success ofRead 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

While in many ways similar to pharmaceutical drug development, medical device development must work through some unique challenges, including: Variations in complexity — Devices may have multiple different constituent parts, including hardware, software, and medicinal components. Very different purposes — Almost all drugs are therapeutic, while devices may be therapeutic, diagnostic, monitoring, supportive, surgical, and more. Regulations regardingRead 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

We’ve previously discussed several issues around psoriasis, including the pathogenesis of the condition and the challenges (and solutions!) of conducting psoriasis clinical trials. Today we turn toward three strategies for treating it. Although moisturizer may be an effective solution for some cases of mild psoriasis, many patients require medical intervention to ease their symptoms andRead 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

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 thatRead more

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’llRead more

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 ratesRead more

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 mechanismsRead more

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