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Optimizing operational efficiencies in early phase trials: The Pediatric Trials Network experience
| Content Provider | Scilit |
|---|---|
| Author | Wade, Kelly Smith, P. Brian Berezny, Katherine Laughon, Matthew |
| Copyright Year | 2016 |
| Description | Journal: Contemporary Clinical Trials 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. |
| Related Links | http://europepmc.org/articles/pmc4997801?pdf=render https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4997801/pdf http://www.contemporaryclinicaltrials.com/article/S1551714416300283/pdf |
| Ending Page | 382 |
| Page Count | 7 |
| Starting Page | 376 |
| ISSN | 15517144 |
| DOI | 10.1016/j.cct.2016.03.002 |
| Journal | Contemporary Clinical Trials |
| Volume Number | 47 |
| Language | English |
| Publisher | Elsevier BV |
| Publisher Date | 2016-03-08 |
| Access Restriction | Open |
| Subject Keyword | Journal: Contemporary Clinical Trials Pediatrics and Child Health Best Pharmaceuticals for Children Act Eunice Kennedy Shriver National Institute of Child Health and Human Development Pediatric Trials Network Pediatric Drug Trials Adverse Events Organizational Improvements |
| Content Type | Text |
| Resource Type | Article |
| Subject | Pharmacology (medical) |