[Clinical trials in children--between the expectations of scientific requirements, the assurance of proven treatment and ethical demands].
Regulation (EC) No. 1901/2006 of the European Parliament and the Council dated 12 December 2008 on medicinal products for paediatric use is the result of a survey by the European Commission, concluding that children in the European Union are inadequately treated with medicinal products. The Regulation is addressed to the pharmaceutical industry with the intention to place medicinal products on the market and to the Member States to register all information on medicinal products for the treatment of children. The pharmaceutical industry will be obliged to conduct clinical trials in children for new medicinal products and medicinal products still under patent. This will be supported by incentives and rewards. As a consequence of the requirement to conduct clinical trials in children the framework and conditions have to be defined and ethical considerations have to be respected.
Lehmann
B
B
Bundesinstitut für Arzneimittel und Medizinprodukte, Kurt-Georg-Kiesinger Allee 3, 53175, Bonn. blehmann@bfarm.de
Mentzer
D
D
Fischer
T
T
Mallinckrodt-Pape
K
K
D000293:Adolescent; D002648:Child; D002986:Clinical Trials as Topic / Q000941:ethics / Q000331:legislation & jurisprudence*; D017277:Drug Approval / Q000331:legislation & jurisprudence; D004345:Drug Industry / Q000941:ethics / Q000331:legislation & jurisprudence; D032984:Ethics, Research; D005858:Germany; D006801:Humans; D007258:Informed Consent / Q000941:ethics / Q000331:legislation & jurisprudence; D010330:Patents as Topic / Q000941:ethics / Q000331:legislation & jurisprudence; D018579:Patient Selection / Q000941:ethics*; D036302:Therapeutic Human Experimentation / Q000941:ethics / Q000331:legislation & jurisprudence