Premier Perspectives Blog

Insider Insights in Clinical Development

Article 50 was triggered on March 29, 2017, and officially started the two-year negotiation period before the U.K. exits the European Union. The uncertainty of Brexit has left researchers and others in the clinical trials industry nervous about their future. Many of the largest changes for researchers in the U.K. depend on what happens during the nextRead more

For a Clinical Endpoint Committee (CEC) to make important decisions, it needs the data to do so. That’s why developing an effective and reliable endpoint data capture strategy is a vital part of working with a CEC. Before starting a clinical trial, sponsors should be able to answer these questions. 1. What needs to be defined?Read more

The journey to treating fibromyalgia has taken a sometimes circuitous path. After a burst of activity about a decade ago, the pursuit of new therapies took a years-long pause before reigniting in recent years. In the past five years, we’ve performed 16 fibromyalgia clinical trials (more than any other CRO), and here are some reflectionsRead more

Acne — specifically acne vulgaris — is the most common skin disorder in the United States, affecting up to 50 million Americans each year. While many cases are restricted to mild manifestations during one’s teenage years, acne is a highly visible condition that can have a major impact on a patient’s quality of life. It’s a disorder with the potentialRead more

One of the first steps in the development process is to create the target product profile (TPP) that defines the projected marketed product label. The TPP helps rule out any pharmacodynamic effects that are no more beneficial than current therapeutic treatments. Developing a TPP is also an opportunity to evaluate intellectual property and ensure that the product has anRead more

In the early days of fibromyalgia drug research, trial site selection centered almost exclusively on rheumatologists and pain centers. But with more drugs on the market and still more studies underway, there has been significant expansion in the number of sites equipped to conduct this research. Up to a point, anyway. As fibromyalgia therapy matures,Read more

In our previous CECs blogpost, we reviewed why Clinical Endpoint Committees (CECs) are so crucial for successful trials today. But just how do sponsors establish and operate a CEC? It’s a complex process that can be broken down into these eight key steps: 1. Understand the deep level of commitment required in putting a CEC together.Read more

Back to Perspectives Blog Home Patient and parent engagement is crucial for successful pediatric drug trials. That’s why the best strategies are ones that encourage proactive involvement beginning at the early stages of protocol development through study conduct and eventual results-sharing. And that includes input. We partnered with iCAN in 2015 to ask pediatric patients, their family members,Read more

Bringing a novel drug to market can be a long, perilous journey down the clinical testing pipeline, taking upwards of 10 to 15 years. Maintaining research and development productivity while navigating the ever-changing regulatory landscape, the choppy waters of today’s reimbursement environments, and the rising tide of clinical trial costs is increasingly challenging. Medicines that failRead more

Also called Endpoint Adjudication Committees, Clinical Endpoint Committees (CMEs) are an increasingly common component of drug development and medical device evaluation. A CEC is a centralized decision-making body for safety and efficacy endpoints. The goal of a CEC is to standardize outcomes and optimize data quality, ultimately driving study success. A CEC addresses the challengeRead more

Placebo response is an ever-present threat in analgesia clinical trials, and failure to sufficiently prove the efficacy of the researched compound can easily doom your promising new product. The risk can be especially pronounced when studying drugs to treat fibromyalgia. Fibromyalgia patients can be — and don’t use the term casually or critically — needy.Read more

As researchers seek to harness the human immune system to fight cancer, they’re looking at several emerging opportunities to expand use of biomarkers. Among them: Human leukocyte antigen typing. Microbiome analysis for determining risk of inflammatory complications with immune therapeutics. Tumor mutation burden, measured via whole genome sequencing, whole exome sequencing, or comprehensive gene panelRead more

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