Premier Perspectives Blog

Insider Insights in Clinical Development

Our seventh installment of The Placebo Problem continues our look at the increasingly high placebo response that is plaguing clinical trials in analgesia and psychiatry. Check out the other posts here. The placebo response is broad. It goes far beyond the effects of merely consuming a sugar pill; it is the patient’s response to theRead more

Before starting Phase I trials, an Investigational New Drug (IND) application must be approved by the FDA. This critical early step in clinical trial development grants an exemption to laws prohibiting the transportation of drugs across state lines prior to market approval. The three major required areas of information in an IND include: Animal pharmacologyRead more

This is the next installment of our look at the increasingly high placebo response that is plaguing clinical trials in analgesia and psychiatry. Check out the other posts here. Over the past few weeks, we’ve discussed the psychological, neurobiological, and genetic mechanisms responsible for the placebo response. Today, we turn to the study designs used inRead more

Strategic partnerships between sponsors and CROs are an important part of today’s clinical research landscape. When managed effectively, these relationships provide customers with collaborative strategic resources that drive optimized solutions. Partnerships help ensure the continuity of project teams and operations, development of best practices for continuous learning, and streamlined resource planning and staffing. They can also provideRead more

This is the fifth installment of our look at placebo response issues in analgesia and psychiatry clinical trials. Read other posts in the series here. Studies examining genetic variants associated with high or low placebo responses – the “placebome” – are relatively recent, but represent an important line of research that can yield insights intoRead more

Acne is a common, complex skin disorder most people experience at some point in their lives. While many treatments are currently available, options for severe acne are limited. Additionally, clinicians are aiming to reduce long-term broad-spectrum antibiotic use, which is becoming less effective as antibiotic resistance becomes more common. Possible solutions? More effective topical treatments and targeted therapies. HereRead more

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

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