Premier Perspectives Blog

Insider Insights in Clinical Development

In clinical drug research, time is of the essence. Not only are researchers, in many cases, trying to beat their competitors to market, their ability to conduct a timely clinical trial can be the difference between life and death for the target audience. The question is, then, how do you as a sponsor get your contract research organizationsRead more

One of the most rewarding efforts I’ve seen in my years working with Premier Research is watching our Rare Disease Day activities unfold. Every year we ask our employees to support Rare Disease Day in some way, so we can all remember how crucial our role is in clinical development, especially in this area ofRead more

With increasing demands for evidence of clinical efficacy and safety, applying sound research practices to medical device development is crucial for a product’s success. The Need for High Standards in Study Design When bringing a new medical device to the market — or even reevaluating an existing product — device companies must answer to: Regulators placing greater scrutiny onRead more

Dealing with difficult situations is part of the job for project managers in any field, but clinical project managers (CPMs) must overcome a number of unique obstacles on the way to successful study completion. Read on for some of the biggest issues facing project managers today, as well as a few practical strategies for resolvingRead more

Children aren’t little adults: Pediatric populations have needs and physiological factors that set them apart from adults. However, it’s taken time for that philosophy to catch on within the clinical research community at large. When writing protocols for trials of acute pain in pediatric populations, researchers must take these unique needs of children into account to meet regulatoryRead more

The purpose of clinical research is ultimately to help patients. That may sound obvious, but all too often we forget the human side when it comes to clinical trials. For patients with rare cancers, taking their perspectives into consideration is invaluable to quality research. But what specific unmet needs do rare oncology patients have? WhatRead more

While drug discovery has seen major advances over the last few years — especially in the domain of rare disease research — the number of new drug approvals has not kept pace with increasing development costs. However, the innovative use of biomarkers has the potential to change that trend. Biomarkers in Rare Disease Research Biomarkers are objectively measurable characteristicsRead more

Although current limitations in neuropsychological testing may discourage development of treatments for central nervous system (CNS) disorders, some researchers see these unmet needs as an opportunity for innovation. Take a look at three strategies that are improving the validity and viability of neuropsychological testing. Rater Training Success or failure of a CNS trial can come down toRead more

A variety of factors can make it difficult to conduct traditional full-scale clinical trials for new treatments of rare cancers. Consequently, because so little information is available, treatments for rare oncology patients are inadequate or nonexistent. Luckily for both patients and researchers, the FDA and the European Medicines Agency (EMA) have introduced regulations that expedite review and approval of certain investigative drugs. Expedited FDARead more

Central nervous system (CNS) disorders are a diverse group of conditions that include psychiatric, neurological and substance abuse disorders. Unfortunately for patients, treatment options for CNS disorders are often limited (or non-existent). To make matters worse, comparatively few CNS drugs are in the development pipeline. What aspects of CNS disorders contribute to lagging drug development? Read on toRead more

A rare disease, also referred to as an orphan disease, by definition affects a small percentage of the population. Most are genetic and appear early in life, with one in three children with a rare disease dying before their fifth birthday. While the definition of “rare” varies from country to country, the US defines a rare disease asRead more

A rare cancer is often defined as one with an incidence of less than 15 per 100,000. The patient populations of these conditions are so small that traditional clinical trial design strategies can be unfeasible. But, with such a low incidence, just why is rare oncology research so important? Why Rare Oncology Needs Innovation Keep in mindRead more

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