publications

The article “Clinical Trial Application in Europe: What Will Change with the New Regulation?” is now available at the Science and Engineering Ethics journal

On June, 3rd 2015 the article entitled “Clinical Trial Application in Europe: What Will Change with the New Regulation?” has been published on theScience and Engineering Ethics journal. The authors (Viviana Giannuzzi, Annagrazia Altavilla, Lucia Ruggieri and Adriana Ceci), address the challenges derived from the Clinical Trial Regulation recently issued by the European Commission that is changing the European legal framework surrounding clinical trials on medicinal products for human use. In this work, the European rules governing the Clinical Trial Application have been analysed, also dealing with special issues, such as paediatric research and trials involving non European countries. The authors underline the need to overcome the existing lack of harmonization of clinical trial procedures among countries, an aspect which is gaining more and more importance, due to the increasing number of multicentre and multinational studies. You can get access to the free abstract and to the publication by clicking on the following link.

2017-01-03T11:18:08+00:00 07/08/2015|Categories: News|Tags: , , |

“Clinical Trials in Paediatrics — Regulatory and Methodological Aspects” chapter is now online!

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.

2017-01-03T11:18:08+00:00 07/08/2015|Categories: News|Tags: , , |