title: [Clinical trials with minors in Germany--effects of the 12th amendment to the German Drug Code on the numbers of applications to Institutional Review Boards (IRB)].
abstract: OBJECTIVE
  The availability of licensed medication for children and adolescents depends on the frequency of clinical trials within this age group. In Germany legislation the framework for clinical trials was changed essentially in 2004 by the 12th amendment on the German Drug Code (AMG). This paper studies the changes in applications to the IRBs for clinical trials in adults and minors before and after implementation of the 12th amendment.
  
  
  METHODS
  In total four IRB were included in the study. All IRB were located in one German state, all were located at universities or medical schools. Two of the universities have a clinical research unit (CRU) funded by the German Ministry of Research, one of these CRUs has additionally a unit specialised on conducting trials with minors (PadNET). All data were assessed by the applications to the IRB between 2002 and 2006 and analysed by the number of applications, inclusion criteria (with minors or without) and the funding status (investigator initiated trials=IIT or funded by industry).
  
  
  RESULTS
  The total number of applications was stable over the observation period (2002: 1192; 2006: 1231). The number of applications according German Drug Code showed no essential changes (2002: 484; 2006: 504). The number of applications for trials which included minors was low and remained on this low level (2002: 41; 2006: 28). Immediately before and after implementation of the amendment the number of applications increased or, respectively, decreased. IIT with minors constituted a higher proportion of all clinical trials with minors, but in total the number of IIT with minors was low.
  
  
  CONCLUSIONS
  The 12th amendment to the German Drug Code had only slight effects on the number of clinical trials in general and especially on the number of clinical trials with minors. Overall, clinical trial with minors make only a small proportion of all applications for clinical trials to the IRB in Germany. The EU regulation on medical products for children may cause an increasing number of clinical trials with minors in the future.
authors.affiliation: Klinik für Kinder- und Jugendpsychiatrie/Psychotherapie, Ulm. michael.koelch@uniklinik-ulm.de
authors.forename: M
authors.initials: M
authors.lastname: Kölch
authors.forename: C
authors.initials: C
authors.lastname: Märsch
authors.forename: J M
authors.initials: JM
authors.lastname: Fegert
authors.forename: H-D
authors.initials: HD
authors.lastname: Lippert
mesh_terms: D000293:Adolescent; D002648:Child; D002675:Child, Preschool; D002986:Clinical Trials as Topic / Q000331:legislation & jurisprudence* / Q000706:statistics & numerical data*; D017277:Drug Approval / Q000331:legislation & jurisprudence*; D028744:Ethics Committees, Research; D005260:Female; D005858:Germany; D006801:Humans; D007223:Infant; D007231:Infant, Newborn; D008297:Male; D033242:Minors / Q000331:legislation & jurisprudence*; D012107:Research Design / Q000331:legislation & jurisprudence* / Q000706:statistics & numerical data*; D035842:Research Subjects / Q000331:legislation & jurisprudence*; D055815:Young Adult