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A survey in 2000 revealed that only about 30% of the prescriptions in the European pediatric population were on the basis of evidence-based medicine (EbM). Less for radiopharmaceuticals and principally for diagnostics, radiologists throughout Europe are referred to the pediatric guidelines of the European Association of Nuclear Medicine (EANM), as none of the frequently used tracers have been evaluated in clinical trials in the different pediatric subgroups. Following a resolution to address the lack of EbM in children, the European Commission published the Pediatric Regulation EC 1901/2006 and its amendment EC 1902/2006, effective from 2007. This regulation foresees the development of evidence-based medicine in the pediatric population. This is effected through a set of principles like the mandatory pediatric investigation plan (PIP) to be included with the market authorization application (MAA), and the pediatric use market authorization (PUMA) for off-patent pharmaceuticals, and to a very small part radiopharmaceuticals with funding possibilities for pediatric-specific research through the 7th Framework Programme (7FP) of the European Union.
Routine nuclear cardiology examinations indicate heart rate, cardiac rhythm, the height of cardiac pulse and respiration rhythm. It would be of interest to study whether these data, especially if the same tests are repeated, can indicate patients’ well being in the future and perhaps patients’ life span, other factors being equal. Related old theories and suggestions are mentioned. Furthermore, some drugs like I-f channel antagonists and stress tests testing cardiac reserves could support such a study.
Es sollte in dieser Schrift untersucht werden, inwieweit bei Änderungen im Bereich der Planung, Durchführung und Auswertung von klinischen Arzneimittelprüfungen die Bewertung mit wissenschaftlichen oder politischen Begründungen erfolgt und inwieweit wissenschaftliche Regeln für politische Zwecke genutzt werden.
Geleitwort
(2012)