An effective team is critical to the success of any clinical study. And when your product is destined for a market valued at $4-16 billion—such as the AVR (transcatheter aortic valve replacement) and TMVR (transcatheter mitral valve replacement) markets—you want to ensure a particularly strong foundation for your study. You build that foundation with your...
Want to know how to build strong strategic sponsor-CRO partnerships? Commit to the three Ds: Start with a dialogue that establishes the project’s direction, ultimately making a difference in the relationship. In these relationships, a CRO must bring to the table the supplemental expertise a sponsor doesn’t know they don’t have, but needs for success. 1. Foster a Dialogue Bidirectional communication is probably the...
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 issues...
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 in...
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....
Quality Agreements are an effective bridge to a successful future for companies in the drug development sector – putting one in place at the start of the business relationship can prevent problems later. Quality Agreements mitigate risk and increase collaboration between partners. These agreements define timelines and establish responsibility and accountability. They supplement contractual commitments....
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...
DURHAM, N.C., OCTOBER 17, 2017 — Patients with Wolf-Hirschhorn syndrome, a congenital malformation disorder caused by variably sized chromosomal deletions, may have fewer motor-skill and communicative impairments than commonly believed. That’s the conclusion of an article in the European Journal of Medical Genetics co-authored by an expert at Premier Research. Dr. Susanne Schmidt, Premier Research...
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...