Premier Perspectives Blog

Insider Insights in Clinical Development

This is the second of a three-part series. Read the other parts here: Part 1: Understanding How GDPR Affects Clinical Trials Part 3: Key Considerations for Clinical Trial Recruitment At the beginning of a study, there are a number of steps sponsors and CROs must take to ensure compliance with the EU’s General Data ProtectionRead more

As medical device regulations evolve and global, multi-center studies become increasingly common, a growing number of sponsors are turning to independent committees such as Data Monitoring Committees (DMCs) or Clinical Endpoint Committees (CECs) for assistance with clinical trial oversight. However, given that neither the U.S. Food and Drug Administration (FDA) nor the European Medicines AgencyRead more

Months before Britons voted narrowly to leave the European Union (EU) in June 2016, then-U.K. Prime Minister David Cameron called a vote to withdraw from “the gamble of the century” and warned of dire political and economic repercussions. More than two-and-a-half years later, Cameron’s warning sounds more prescient than ever. Countless unanswered questions confront BritishRead more

This is the first of a three-part series. Read the other parts here: Part 2: Ensuring Study Start-Up Compliance With GDPR Part 3: Key Considerations for Clinical Trial Recruitment Since it took effect May 25, 2018, the European Union’s General Data Protection Regulation has been reshaping the way data is handled across every industry sector, includingRead more

Since 2002, doctors and researchers have used a standard rosacea classification system to provide consistent terminology, as well as to facilitate studies, clinical diagnosis, and treatment. However, in 2018, the Journal of the American Academy of Dermatology published a new standard classification system that replaces the previous one[1]. Below is some of the most importantRead more

Of all the truisms that apply to clinical drug research, probably none is more universally accepted than this one: “There’s no substitute for experience.” But if you’re working in an indication that is not widely studied, selecting sites on the basis of experience can be difficult. That’s one of many subjects we addressed in aRead more

Researchers have made many attempts at disease modification as they pursue breakthroughs in treating Parkinson’s disease, but so far without success. Why have these efforts failed, and what’s next in treating this degenerative disorder that affects an estimated 10 million people worldwide? We tackled these questions in a Premier Research webcast, The Potential for DiseaseRead more

Rosacea is a common condition occurring on the convexities of the face and affecting middle-aged persons. It may be caused or worsened by a variety of different factors, including genetics; problems with the blood vessels in the face, the nervous system, and/or the immune system; the presence of Demodex mites; and environmental factors. It isRead more

We were conducting a trial for a painful diabetic neuropathy (PDN) drug and were investigating why one site had an especially high placebo response rate. Then one of our representatives, waiting in the site’s lobby to meet with the principal investigator, pinpointed the likely reason when a patient walked in the door. “Mrs. Jones,” theRead more

Among common degenerative disorders, Parkinson’s disease strikes more frequently than all but one: Alzheimer’s. Parkinson’s affects about 1 percent of the population over age 60 and claims 60,000 new diagnoses in the United States each year.[1] The cause of Parkinson’s remains a mystery, and the dopamine promoter levodopa — notwithstanding its limitations — has beenRead more

Over the last two decades, biologics have improved the management of patients with psoriasis and advanced melanoma, many of whom either did not respond to traditional treatments or experienced severe side effects from them. With their success in deadly forms of melanoma and more common chronic inflammatory conditions such as psoriasis, drug developers are now targeting rarerRead more

Between 7 and 10 percent of the U.S. population suffers from some type of neuropathic pain, and a significant share of those affected require chronic pain treatment.[1] This high rate of occurrence makes our limited understanding of these afflictions, and the long search for effective treatments, all the more frustrating. Treating neuropathic pain starts withRead more

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