Optimizing operational efficiencies in early phase trials: The Pediatric Trials Network experience

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• 作者：Amanda England^a ; ¹ ; Kelly Wade^b ; P. Brian Smith^c ; ^d ; Katherine Berezny^d ; Matthew Laughon^a ; ^{matt_laughon@med.unc.edu" class="auth_mail" title="E-mail the corresponding author} ; on behalf of the Best Pharmaceuticals for Children Act &mdash ; Pediatric Trials Network Administrative Core Committee
• 关键词：BPCA ; Best Pharmaceuticals for Children Act ; NICHD ; Eunice Kennedy Shriver National Institute of Child Health and Human Development ; PTN ; Pediatric Trials Network
• 刊名：Contemporary Clinical Trials
• 出版年：2016
• 出版时间：March 2016
• 年：2016
• 卷：47
• 期：Complete
• 页码：376-382
• 全文大小：277 K

文摘

Performing drug trials in pediatrics is challenging. In support of the Best Pharmaceuticals for Children Act, the Eunice Kennedy Shriver National Institute of Child Health and Human Development funded the formation of the Pediatric Trials Network (PTN) in 2010. Since its inception, the PTN has developed strategies to increase both efficiency and safety of pediatric drug trials. Through use of innovative techniques such as sparse and scavenged blood sampling as well as opportunistic study design, participation in trials has grown. The PTN has also strived to improve consistency of adverse event reporting in neonatal drug trials through the development of a standardized adverse event table. We review how the PTN is optimizing operational efficiencies in pediatric drug trials to increase the safety of drugs in children.