• Langue : Français
• Discipline : Pharmacie
• Identifiant : 2019LILUE118
• Type de thèse : Doctorat de pharmacie
• Date de soutenance : 19/09/2019

Résumé en langue originale

Clinical trials are the backbone of modern evidence-based medicine. However, the volume of clinical trials involving children had been substantially lagging behind their adult counterparts in the early 1990’s for a simple reason, the lack of a proper regulatory framework promoting such development in a very peculiar population. Sadly, because of a lack of knowledge on either the efficacy or the safety of the drugs in the paediatic population at the time, medicine-related tragedies occurred and prompted the authorities to reach a consensus on a much needed regulatory framework, allowing more studies to be initiated in order to obtain paediatric information for medicines used in children. Decades were necessary to define the current regulations in both Europe and the United States, allowing a better development and standard of care for paediatrics thanks to different systems of incentives and rewards put in place to stimulate the development of those drugs. Nonetheless hurdles still exist which hopefully will be tackled in the years to come in this ever evolving field in order to finally reach the same standards of care as the ones observed in the adult population.

Résumé traduit

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