Monthly Archives: October 2017

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

DURHAM, N.C., OCTOBER 20, 2017 — Premier Research’s head of patient engagement will address patients’ emerging role in the development of novel drugs October 23 at the Cambridge Rare Disease Network Summit in Cambridge, U.K. Juliet Moritz, the CRO’s Executive Director for Patient Engagement and Strategic Development, will discuss how patient advocacy groups are greatlyRead 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

DURHAM, N.C., OCTOBER 19, 2017 — Premier Research’s head of patient engagement will address patients’ emerging role in the development of novel drugs October 23 at the Cambridge Rare Disease Network Summit in Cambridge, U.K. Juliet Moritz, the CRO’s Executive Director for Patient Engagement and Strategic Development, will discuss how patient advocacy groups are greatlyRead more

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 ResearchRead 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

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