Monthly Archives: November 2017

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

Early oncology trials have changed for the better over the last few years thanks to novel investigational agents, innovations in trial design, and changes to regulatory practices. Among other improvements, these changes have helped to perfect the way study designers plan early phase dosing. Dosing strategies in Phase I trials First-in-human trials When an investigational agent is administeredRead more

Roughly 47 million people around the world are living with Alzheimer’s disease (AD) — a number that is expected to increase to 75 million by 2030 and 150 million by 2050. Researchers are pursuing a range of treatments: disease modifying, symptomatic treatment and therapy for behavioral issues. Yet no new therapy has been approved sinceRead 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

DURHAM, N.C., NOVEMBER 14, 2017 — By 2030, it’s estimated that 75 million people will suffer from some form of dementia, with the cost of patient care reaching $2 trillion annually. By far the most common form of dementia is Alzheimer’s disease, the target of 143 drugs now in development. Premier Research will examine challengesRead more

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

DURHAM, N.C., November 1, 2017 — Finding the optimal dose, dosing regimen — and, in a growing number of trials, the right combination treatment partner — is essential to developing an oncology therapeutic. Early-phase oncology trial designs must take into account the latest information about emerging therapies, biomarkers, and trial methodology, along with evolving regulations,Read more

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