Monthly Archives: August 2017

This is the fourth in our series examining the increasingly high placebo response issues plaguing analgesia and psychiatry clinical trials. Additional posts in the series are located here. As with many other aspects of placebo research, the majority of research on underlying neurobiological mechanisms has focused on placebo analgesia. In fact, roughly 40 positron emissionRead more

There are many pitfalls that come with preparing an Investigational New Drug application for FDA submission. Luckily, there are also plenty of ways to avoid them. But the most important strategy? It all comes down to one thing: Always remember to keep your audience (the FDA reviewers) in mind as you write. These five actionableRead more

This is the third installment of our look at the increasingly high placebo response that is plaguing clinical trials in analgesia and psychiatry. Additional posts in the series can be accessed here. Solutions to the placebo problem require an understanding of the underlying mechanisms. Broadly, research on contributors to the placebo response falls into twoRead more

When you’re looking into conducting a natural history study, you’ve got two things to consider up front: the premise that underlies all of these studies, and which of several types suits your purpose. We tackled these and other topics in our last rare disease webinar. Natural History vs. Registry Studies in Rare Disease considers aRead more

This is Part Two of our series on the increasingly high placebo response that is plaguing clinical trials in analgesia and psychiatry. Read the other parts here. Analgesic and psychiatric drug development is facing an enormous problem: rising placebo responses in randomized controlled trials (RCTs) threaten the ability of pharmaceutical companies to successfully identify novelRead more

In 1978 the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research issued the Belmont Report, which has since become a pivotal document in medical research ethics. This report pointed to three unifying ethical principles that must be followed in clinical research: respect for persons, beneficence, and justice, which are considered fundamental forRead more

DURHAM, N.C., AUGUST 14, 2017 — Rare diseases afflict tens of millions of people, and for professionals seeking to treat these conditions, it can be tempting to regard patients more as diagnoses and outcomes than as folks seeking to lead otherwise normal lives. That’s why Premier Research has signed on as a presenting sponsor ofRead more

For hundreds of years, the medical community has known that the mere act of receiving treatment, even if it’s just a sugar pill, can improve a patient’s symptoms. Therefore, in order to ensure that the effects of an experimental treatment are real, most randomized controlled trials (RCTs) include a placebo arm. Placebos are most oftenRead more

DURHAM, N.C., August 7, 2017 — Premier Research announces the appointment of Nach Davé, RPh, MS, as Vice President of Global Regulatory Affairs. He oversees the company’s regulatory affairs service offerings in rare diseases and across its broad range of therapeutic focus areas, bringing to the position more than 20 years of experience in theRead more

Acne is a common chronic inflammatory skin condition with a complex pathophysiology involving multiple factors. Effective types of treatment involve both prescription and over-the-counter remedies that may be topical or systemic. While many popular therapies have been available for decades, today’s patients and physicians have more options for acne management. Additionally, new research and novelRead more

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