Premier Research participated at the ACRP 2012 Global Conference, April 16-18 in Houston, Texas. Dr. Charlene Sanders, M.D., Vice President, Global Regulatory Affairs & Pediatric Strategic Consulting and Angi Robinson, Executive Director, Clinical Trials Management led a session entitled “Successful Pediatric Studies: Key Study Design and Site Selection Considerations.”
The industry recognizes the importance of ensuring the safety and well-being of children involved in research studies. Medical and regulatory bodies have worked to provide a framework to support appropriately designed studies through regulations and guidance documents in this vulnerable population. However, it is crucial to understand the nuances associated with pediatric trials, for the site, patient and family, in order to manage them to successful completion.
The presentation explored topics including the evaluation of study design considerations such as duration of treatment, required assessments, use of placebo, and inclusion of specific age groups; selection of appropriate sites for pediatric trials and the unique needs of these sites; identification of pediatric recruitment/retention hurdles and site specific strategies to overcome these as well as a reflection on ethical concerns related to pediatric research.
Premier Research expertise guides sponsors in developing novel approaches to successfully manage pediatric clinical trials in order to gain regulatory approval and fulfill pediatric requirements. Premier Research understands that special protections must be given to children participating in clinical research and the challenges associated with successfully running these trials. The company has the experience with pediatric trial design and execution to ensure that while children benefit from medical progress, they are not exposed to unnecessary risks by participating in clinical trials.