Pediatric drug development may be thought of as more noble than adult clinical research, with investigators determined to uncover new treatment options for kids. Unfortunately, the job of investigative sites in attracting and converting patients for pediatric studies can be considerably more daunting.

Starting in the 1950s, pediatric clinical research networks were initially formed around more acute conditions such as oncology and rheumatology. Investigators recognized the power of combining resources in order to recruit the right type and quantity of patients to advance clinical research for new treatments.

Pediatric clinical research networks have flourished in the last 60 years and a wide range of specialty care, primary care and disease-specific networks exist to not only improve the coordination, speed and quality of randomized controlled trials, but in some cases to also study critical drugs to improve labeling for pediatric use.

Join speakers Brian Smith, Associate Professor of Pediatrics, Duke Clinical Research Institute Member, Pediatrics Trial Network Steering Committee and Peter Clayton, Professor of Child Health & Paediatric Endocrinology, University of Manchester, Network Director of the Greater Manchester, Lancashire and South Cumbria Medicines for Children Research Network (GMLC), for a 60-minute + Q&A webinar discussion on:

• The evolution and current landscape of pediatric clinical research networks
• Selecting and engaging with the right network for your pediatric trial
• Enhancing your pediatric clinical research process while fostering high-quality, ethical research on medicines for use in children

This webinar is part of a series on Pediatric Clinical Trials

Dr. Brian Smith received his MD from Mercer University School of Medicine in 2001. He completed a residency in pediatrics and fellowship in neonatology at Duke University Medical Center in 2004 and 2007, respectively. He received a Masters of Health Sciences in Clinical Research in 2006 from Duke University and a Masters of Public Health in biostatistics from the University of North Carolina at Chapel Hill in 2009. Dr. Smith is the chief of the Division of Quantitative Sciences in the Department of Pediatrics and is Associate Professor of Pediatrics at Duke University Medical Center.

Dr. Smith was employed at FDA (2006-2010) in the Office of the Commissioner as Senior Pediatric Consultant. He leads a Department of Health and Human Services funded project implementing comparative effectiveness research in 300 Neonatal Intensive Care Units across the US. Dr. Smith is the principal investigator for the ACCELERATE study in which data from >700,000 critically ill neonates is stored at the Duke Clinical Research Institute (DCRI), where he has served as the associate director of its Fellowship Program since 2010.

Dr. Smith is a member of the Pediatric Trial Network Steering Committee. His areas of research interest include the safety and dosing of therapeutic agents in children and has led multiple investigations of the safety and dosing of antimicrobials in neonates.

Professor Clayton graduated from Manchester University Medical School in 1984 (Distinction in Paediatrics), having obtained a first class degree in Physiology & Pharmacology in 1981. He did his early paediatric training around Manchester before embarking on an academic career in Paediatric Endocrinology. His MD thesis was on "Growth Patterns after Neuroaxis Irradiation in Childhood.". He spent time at the University of Virginia, USA as a MRC Travelling Fellow in 1990/1 with his work there primarily directed at molecular endocrinology in the laboratory.

He returned to Manchester to establish a research group of both clinicians and scientists, working under the broad remit of investigating normal and abnormal growth from clinical, biochemical and molecular perspectives. He took up a Senior Lectureship in Child Health in 1994, and was promoted to Professor of Child Health and Paediatric Endocrinology in 2001. He was lead for the Division of Human Development in the Manchester Medical School from 2001-2007.

He has >200 publications on clinical and basic science aspects of paediatric endocrinology. He has served on the editorial boards of a number of endocrine journals, and is currently an associate editor of Hormone Research and on the board of Clinical Endocrinology. He is on the councils of the Growth Hormone Research Society and the Society for Endocrinology. He is on the medical committee of the UK Pituitary Foundation. Professor Clayton is also the Network Director of the Greater Manchester, Lancashire and South Cumbria Medicines for Children Research Network (GMLC), which helps local staff at NHS organisations to increase the number of children enrolled into MCRN adopted clinical trials and other paediatric research studies on the NIHR Clinical Research Network study portfolio.

Ms. Bohannon provides global operational and strategic leadership for INC Pediatrics. She has 16 years of diverse operational and therapeutic experience within pharmaceutical research and development; including Phase I-IV clinical research, laboratory R&D, US and global project management, and sales & marketing. Ms. Bohannon has over 9 years of pediatric research experience including 5 years of pediatric study and program management within the Best Pharmaceuticals for Children Act – Coordinating Center (BPCA-CC) under the purview of the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD).

Ms. Bohannon has supported development and management of pediatric projects across multiple therapeutic areas (analgesia, cardiovascular, CNS, dermatology, infectious disease, hematology, metabolic disease and respiratory) and clinical settings (inpatient, outpatient, ICU, OR and ER), including rare diseases/orphan indications. Her pediatric experience includes protocol and program development in compliance with FDA PREA and BPCA legislation, and the European Paediatric Regulation; internal team training and management from project initiation through completion; recent presentations examining pediatric research practices and opportunities for further training and education; and strategy development for navigating the challenges of pediatric research.

INC Research is a therapeutically focused contract research organization with a high performance reputation for conducting global clinical development programs of the highest integrity. Pharmaceutical and biotechnology companies look to INC Research for a complete range of customized Phase I through Phase IV programs in therapeutic areas of specialty, and in innovative pediatric and women's health trials. The company's The Trusted Process® methodology and therapeutic foresight leads customers to more confident, better-informed drug and device development decisions. INC Research is headquartered in Raleigh, North Carolina. For more information please visit http://www.incresearch.com/