On June, 2015, the chapter entitled “Clinical Trials in Paediatrics — Regulatory and Methodological Aspects” and included in the book Drug Discovery and Development – From Molecules to Medicine, ISBN 978-953-51-2128-2, edited by Omboon Vallisuta and Suleiman Olimat has been released online.
This chapter has been written with the contribution of Adriana Ceci, Viviana Giannuzzi, , Donato Bonifazi, Mariagrazia Felisi Fedele Bonifazi and Lucia Ruggieri on behalf of TEDDY-CVBF (Consorzio per Valutazioni Biologiche e Farmacologiche).
The aim of this chapter is to describe the requirements for implementing paediatric clinical trials in compliance with the principles of Good Clinical Practice (GCP), in order to be part of an approved PIP (Paediatric Investigational Plan-EMA) or PSP (Paediatric Study Plan-FDA). The chapter addressed the main three topics of a paediatric clinical trial: the regulatory aspects, the paediatric plans and paediatric trials methodology and the incentives provided by the existing legislation and the main results achieved by today.
The chapter also explores the distribution and the other characteristics of recently conducted paediatric trials in Europe and in the United States, also providing a comparison between the two areas.
At this link you can get access to the full article.