Monthly Archives: April 2017

The Initiative on Methods, Measurement, and Pain Assessment in Clinical Trials (IMMPACT) is a major group providing guidance for design considerations of acute pain clinical trials. IMMPACT is made up of a team consisting of some of the most respected researchers and clinicians in the field of pain medicine. As of 2016, IMMPACT recommends these ten best practicesRead more

Atopic dermatitis (AD), also known as atopic eczema, is a common skin disorder affecting millions of people worldwide. While many cases are mild, AD can take a significant financial and emotional toll on patients and their loved ones. What are the symptoms of atopic dermatitis? AD is characterized by skin barrier function abnormalities and skinRead more

Psoriasis is an autoimmune disease that affects 7.5 million people in the United States and roughly 100 million worldwide. While its main manifestation is in unsightly, often irritating skin lesions, many patients also experience painful psoriatic arthritis. Additionally, psoriasis often comes with a wide range of other chronic conditions, including Type 2 diabetes, cardiovascular disease andRead more

Short-duration acute pain management trials involve a variety of complex factors that must be taken into account for successfully evaluating the safety and efficacy of a new analgesic product. These five considerations are key. 1. Choosing the Right Model There are a number of established pain models for clinical research, each with its own type, intensity,Read more

DURHAM, N.C., April 20, 2017 — Premier Research’s Chief Medical Officer will lead a panel discussion on patient-centric research on April 20 at the World Orphan Drug Congress (WODC) in Washington, D.C. Dr. Colin Hayward will examine what patient-centricity means and where it’s taking the clinical research industry, joined by panelists Jayne Gershkowitz of AmicusRead more

Knowledge of a disease’s natural history is essential to building the scientific foundation for an effective clinical development program. That’s especially the case when developing drugs to treat rare diseases, which by their very nature are poorly understood. Natural history studies don’t just track the course of diseases over time, but identify demographic, genetic, environmental,Read more

Designing and conducting psoriasis clinical trials is tricky. After all, psoriasis is a highly variable group of conditions that produce a range of debilitating and often subjective symptoms. So how do researchers assess efficacy in novel psoriasis treatments? Read on for the answer. Considerations for Psoriasis Trials In clinical practice, broad global assessments are usedRead more

When it comes to analgesic drug development, it’s important to optimize design of early phase trials. The main objectives of studies at this stage are to: Explore a range of doses Obtain data on onset, peak effect, and duration Assess relative efficacy in comparison to established analgesics To accurately evaluate their product, sponsors need toRead more

Patient registry and natural history studies are often thought of as interchangeable, but there are major differences in these approaches to clinical drug development. Understanding the role of each is important, as well as understanding the distinctions on how these study designs are used in pursuing treatments for rare diseases. Patient Registries A patient registryRead more

Psoriasis is caused by dysregulated interactions of the innate and adaptive immune system in skin epithelium and connective tissue, including the activation and proliferation of T helper cells. As an autoimmune disorder causing widespread inflammation, it is unsurprising that psoriasis is associated with a number of non-dermatological conditions. Continued psoriasis research may give insight into the etiologyRead more

Phone Us Now
Email Us Now