title: Integration of pediatric aspects into the general drug development process.
abstract: Drug treatment of children is today less regularly based on formal clinical testing than adults. This has led to concerns regarding the safety and efficacy of pediatric medicines and resulted in public action in the United States and the European Union. The reasons for the increasing awareness include better understanding of child physiology, increased trust in GCP (good clinical practice), improved treatment of several severe childhood diseases, a changed view of the child as a subject in society, and more. The US has successfully introduced pediatric legislation that facilitates participation of children in phar maceutical innovation, and comparable approaches are now being discussed in Europe and Japan. While the outcome of the EU pediatric regulation in the near future is still open, the US pediatric legislation has been highly successful over the past 8 years and will be revised before it expires in September 2007. Innovative drugs are today being developed by global pharmaceutical companies. Adding pediatric aspects to this development process is a complex task where companies need to build up internal competency. Bureaucratic procedures that could be harmful to the companies' economic fundaments need to be avoided, and an appropriate ethical framework is required. This needs to be addressed by all partners in healthcare, including regulatory authorities, the pharmaceutical industry, pediatricians, patients and others in a sense of shared responsibility.
authors.affiliation: F. Hoffmann-La Roche Ltd., Pharmaceuticals Division, Basel, Switzerland. klaus.rose@roche.com
authors.forename: K
authors.initials: K
authors.lastname: Rose
mesh_terms: D002626:Chemistry, Pharmaceutical / Q000379:methods*; D002648:Child; D002986:Clinical Trials as Topic / Q000331:legislation & jurisprudence*; D017277:Drug Approval; D015195:Drug Design; D004345:Drug Industry; D005060:Europe; D006801:Humans; D007880:Legislation, Drug; D010601:Pharmacology, Clinical; D013678:Technology, Pharmaceutical