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 administered...
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 to...
Immuno-oncology is a unique approach to cancer treatment that leverages the body’s immune system to help fight cancer. In recent years, immune checkpoint inhibitors have changed the landscape of immunotherapy, and emerging therapies such as chimeric antigen receptor T-cells (CAR-T), dendritic cell vaccines and bi-specific T-cell engager (BiTE) antibodies are pushing the envelope even further....
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 of...
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 there...
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 popular...
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 and...
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...