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QuintilesIMS Blog

Fresh ideas and insights from our experts around the globe

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Brazilians flock to pharmacies: How healthcare companies can bolster sales by embracing this shifting shopper trend
CynthiaJackson
The best way to secure qualified investigators for a clinical trial is to have an institution-specific point person, or navigator contact them directly about the opportunity. This was one of the main findings of the Point Person Project , a multi-institute study lead by Dr. Jonathan M. Davis of Tufts Clinical and Translational Science Institute (CTSI) that included child health experts from the Quintiles Pediatric Center of Excellence and other leading institutions. The goal of the Point Person Project was to identify the best strategies to identify and engage the most qualified and interested investigators to participate in pediatric clinical trials. A good investigator can help overcome many of the obstacles faced on clinical trials, because they understand the complexities of...
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PaulSutton
Both outcomes audits and outcomes evaluations are powerful research tools designed to collect and interpret real-world data for a specific patient population. Whereas an outcomes audit uses data extraction retrospectively to view a patient’s progression on a drug treatment, an outcomes evaluation is more of a prospective process – comparing initial measurements from a patient with measurements taken at intervals during the course of their treatment. Previously, we have written how an outcomes evaluation can benefit biopharma, however in this article we will examine how outcomes evaluations can help the NHS to optimally manage its patients by tracking clinical and economic drug outcomes. Real-world data challenges facing the NHS The NHS is under pressure to deliver efficient...
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LynnHughes
Research into Parkinson’s Disease has been stymied in recent years due to an increase in placebo response rate among patients in Phase III trials. This unexpected consequence may have sidelined drugs that had positive potential as a treatment for this terrible disease -- and we wanted to find out why. Substantial improvement of Parkinsonian symptoms is observed in placebo groups of many Parkinson’s Disease clinical trials contributing to a number of negative and failed studies. The Neurology Center of Excellence team at Quintiles conducted a retrospective analysis of 20 pivotal Phase III global clinical trials, performed from 2000-2014, of patients with early and advanced Parkinson's Disease, to identify factors contributing to increased placebo responses. Here’s what we found: ...
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Nigel Rulewski
In a historic step, on March 6, 2015 the U.S. Food and Drug Administration (FDA) approved the first ever biosimilar product for the U.S. market.  An abbreviated licensure pathway for biosimilars approval in the US was created in 2010 through the Biologics Price Competition and Innovation Act, which is part of the Affordable Care, but this is the first drug to make it through that process.
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Biosimilar Use and Uptake in Europe
The European Medicines Agency (EMA) has recently updated its overarching guidance on principles for biosimilar development. A key recent change is to allow biosimilar developers to use a comparator authorized outside the European Economic Area (EEA) as part of the clinical investigation of a biosimilar, which potentially eliminates the need to repeat clinical trials for multiple markets. This is an exciting development for the EU healthcare industry, as the guidelines will help streamline the process by which biosimilars can be brought to market, and suggests that regulators are open to these treatment options. To date, the EMA has approved more than 20 biosimilars , including the first two monoclonal-antibody biosimilars. As a result, the EU region has gained significant...
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Biosimilar Use and Uptake in Europe
The European Medicines Agency (EMA) has recently updated its overarching guidance on principles for biosimilar development. A key recent change is to allow biosimilar developers to use a comparator authorized outside the European Economic Area (EEA) as part of the clinical investigation of a biosimilar, which potentially eliminates the need to repeat clinical trials for multiple markets. This is an exciting development for the EU healthcare industry, as the guidelines will help streamline the process by which biosimilars can be brought to market, and suggests that regulators are open to these treatment options. To date, the EMA has approved more than 20 biosimilars , including the first two monoclonal-antibody biosimilars. As a result, the EU region has gained significant experience...
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Louise P
Gathering clinical trial data is an integral component of the value delivery process. But these data don’t address the simultaneous need for data about real-world outcomes. This disparity is creating an information gap that if not addressed will make it increasingly difficult to secure market access for new therapies. In the last several years, the lens has widened from an almost singular attention on clinical outcomes to a much broader focus on combined clinical, economic and humanistic outcomes. This is putting increased pressure on biopharma companies to deliver more holistic evidence, including real-world outcomes, to support healthcare-decision making in support of their products. At the same time, unprecedented access to new data channels, innovative designs and improved...
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RobinHuff
Pediatric patients are not tiny adults – but they aren’t Martians either. * They are children, and when involving them in a trial, we need to take into account all of the physiological, social, cultural, and developmental differences that make them unique. When planning a clinical trial that involves children, keep the following in mind. Tests must be age appropriate . Researchers often try to retrofit adult trials for children by merely shifting the age range specified in the protocol. But they don’t always consider the practicalities of the testing instruments - how a child will complete required tasks. Imagine for example, asking a toddler to complete a six-minute walk test. It’s a standard test for adult patients, but would be ridiculous for a toddler. I've not known one...
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Niti Goel
For a half century, lupus patients – most of them women – had few treatment options and no signs of hope in the world of drug development. But in 2011, when the first new drug approved for systemic lupus erythematosus in more than 50 years entered the market, a new wave of confidence swept across the drug development industry. Today numerous treatments are in development to address this chronic inflammatory disease. Yet, challenges remain for biopharma companies striving to create new drugs for this uncommon disease. A group of experts from Quintiles’ Rheumatology Center of Excellence recently conducted a novel analysis of lupus clinical studies registered in ClinicalTrials.gov between 2004 and 2013 and discovered that there was a three-fold increase in the number of patients...
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Kimberly Robasky
Molecular testing has been around for decades and with a broad spectrum of utility: blood typing in hematology, DNA-fingerprinting in forensics, and HLA-typing in immunology, to name just a few. More recently, game-changing breakthroughs in DNA-sequencing are enabling broader and even more accurate assays, further accelerating discovery and directly impacting how we deliver care. DNA-sequencing has many applications. For example, targeted sequencing focuses on regions of interest, such as specific genes or loci of important personal variation.  By contrast, whole-genome DNA-sequencing accesses the entire genome, identifying many more personal variations. On the other hand, transcriptome sequencing (a.k.a., RNA-Seq) accesses the RNA to understand how certain genetic variations affect...
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