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The pediatric module at the coordination center for clinical trials heidelberg‐an approach to improve quality and conduct of clinical drug trials in children
Author(s) -
Ebert U.,
Feneberg R.,
Toenshoff B.,
SeibertGrafe M.
Publication year - 2004
Publication title -
clinical pharmacology and therapeutics
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.941
H-Index - 188
eISSN - 1532-6535
pISSN - 0009-9236
DOI - 10.1016/j.clpt.2003.11.090
Subject(s) - clinical pharmacology , medicine , clinical trial , food and drug administration , competence (human resources) , german , christian ministry , adverse effect , drug , clinical research , pediatrics , medical physics , pharmacology , psychology , social psychology , philosophy , theology , archaeology , history
Relatively little medical research is performed in the field of clinical pharmacology in pediatrics. The US Food and Drug Administration (FDA) estimates that nearly 80% of all drugs prescribed for children have never been tested in pediatric patients, and are thus used “off‐label”. However, off‐label use of drugs in children results in a doubling of adverse events as compared to drugs validated sufficiently (6% vs. 3%). Therefore, well planned, randomized, prospective studies are necessary to generate valid data on efficacy, safety, pharmacokinetics, and pharmacodynamics of drugs frequently used in children. For that purpose, the Pediatric Module located at the Coordination Center for Clinical Trials (KKS) Heidelberg is funded by the German Ministry of Education and Research since October 2002. The goal is support of clinical studies in children by establishing competence and infrastructure to ensure high quality of pediatric studies as well as building a pediatric network in order to optimize conduct of clinical studies. The Pediatric Module Heidelberg offers project coordination, study assistance, clinical monitoring, and quality assurance as well as education and training. It works in cooperation with the University Children's Hospital, the recently established Pediatric Network (PaedNet) at German universities, other hospitals, and pediatricians in private practice. All of them contribute to the success of the network to optimize drug therapy in children. Clinical Pharmacology & Therapeutics (2004) 75 , P24–P24; doi: 10.1016/j.clpt.2003.11.090