title: German Paediatric Research Network (PAED-Net).
abstract: Clinical trials in children are mandatory to generate data on new drugs as well as on drugs used off-label or for unlicensed indications. The EU Paediatric Regulation introduced in 2007 provides the background, goals, and requirements for pediatric clinical trials. The German Paediatric Network (PAED-Net) was established in 2002 with a public grant from the German Ministry of Education and Research with the aim of developing competence, infrastructure, networking, and education for pediatric clinical trials. The network, consisting of six pediatric clinical units and a coordinating office, has progressed very well and has achieved valuable improvements concerning the conduct of pediatric clinical trials. In addition, training programs have encouraged knowledge about clinical trials in investigators and nurses and have made medical professionals as well as the public aware of the need and advantages of trials in children. Although these trials are still challenging from the ethical, scientific, and clinical points of view, quality-controlled data are the prerequisite for sharing therapeutic innovations for children and for applying the principles of evidence-based medicine to the youngest patient population.
authors.affiliation: Interdisciplinary Centre for Clinical Trials (IZKS), University Medical Centre Mainz, Mainz, Germany. seibert-grafe@izks-mainz.de
authors.forename: Monika
authors.initials: M
authors.lastname: Seibert-Grafe
authors.forename: Raunhild
authors.initials: R
authors.lastname: Butzer
authors.forename: Fred
authors.initials: F
authors.lastname: Zepp
mesh_terms: D035843:Biomedical Research / Q000941:ethics / Q000331:legislation & jurisprudence*; D002648:Child; D002986:Clinical Trials as Topic / Q000331:legislation & jurisprudence* / Q000592:standards*; D005062:European Union; D005858:Germany; D033161:Government Regulation; D006801:Humans; D010372:Pediatrics