PHILADELPHIA, September 30, 2015 — Performing research on children is critical for determining the safety and efficacy of medications in pediatric populations. Yet the National Institutes of Health says seven in 10 medicines given to children have been tested only in adults, leaving a large need for pediatric studies. With the permanent extension of the Pediatric Research Equity Act of 2003 and similar legislation in Europe, pediatric trials are more commonplace than ever.
In a poster presentation at the American Medical Writers Association’s 75th Annual Conference in San Antonio, Premier Research medical writer Jennifer Strickler will describe the main differences between pediatric and adult study designs, outline the medical considerations pediatric protocols should include, and break down protocol elements specific to children and family participation.
Strickler will present Easy as ABC? Adapting Pediatric Protocol Designs from Existing Adult Data and Study Templates on behalf of a team of authors that also includes Thomas Laage, MD; Emily Stube; and Charlene Sanders, MD. She will demonstrate key pediatric considerations for ensuring safe enrollment of children and creating study designs that are acceptable to the referring physician, the investigator, the child, and the child’s guardian.
About Premier Research
Premier Research is a leading contract research organization serving the needs of biotechnology, pharmaceutical, and medical device companies worldwide. The company has a wealth of experience in the execution of global, regional, and local clinical development programs, with a special focus on addressing unmet needs in such areas as analgesia, CNS, rare diseases, medical device and diagnostics, and pediatric research. Premier Research operates in 50 countries and employs more than 1,000 professionals, including a strong international network of clinical monitors and project managers, regulatory, data management, statistical, scientific, and medical experts. With its mission to improve productivity in clinical development, the company aligns itself with the mission of its customers to bring new medical treatments to patients promptly, accurately, and cost-effectively.