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.