Clinical Trial Application in Europe: What Will Change with the New Regulation?

TitleClinical Trial Application in Europe: What Will Change with the New Regulation?
Publication TypeJournal Article
Year of Publication2016
AuthorsGiannuzzi, V, Altavilla, A, Ruggieri, L, Ceci, A
JournalScience & Engineering Ethics
Volume22
Issue2
Pagination451-466
Date Published2016
Publication Languageeng
ISBN Number13533452
KeywordsClinical , DATABASES , Europe , Harmonisation , Medical , regulatory
AbstractThe European framework surrounding clinical trials on medicinal products for human use is going to change as demonstrated by the large debate at European institutional level. One of the major challenges is to overcome the lack of harmonisation of clinical trial procedures among countries. This aspect is gaining more and more importance, considering the increasing number of multicentre and multinational studies. In this work, the actual European rules governing the Clinical Trial Application have been analysed throughout the different steps including the registration of the trial in the European database; the preparation of documents to be submitted and their contents; the preparation of documents related to the information and consent process; the submission to competent bodies. Specific issues related to paediatric research and trials involving non EU/EEA countries have been addressed as well. Results reveal that the European legislation offers a well defined set of European rules covering different aspects of a Clinical Trial Application. However, these are not suitable to meet the challenges from multicentre and multinational clinical studies. A stronger set of rules, such as is available in a composite European Regulation has been adopted and is expected to harmonise practices and enable sponsors to carry out well conducted trials. But will the new regulation overcome the existing criticisms of Directive 2001/20/EC? 
NotesGiannuzzi, Viviana 1; Email Address: vg@benzifoundation.org Altavilla, Annagrazia 2 Ruggieri, Lucia 1 Ceci, Adriana 1; Affiliation: 1: Fondazione per la Ricerca Farmacologica Gianni Benzi onlus, Via Abate Eustasio, 30 70010 Valenzano Italy 2: Espace Éthique Méditerranéen, UMR 7268 ADES - Aix-Marseille Université/EFS/CNRS, Hôpital Adultes de la Timone, 264, Rue Saint Pierre 13385 Marseille France; Source Info: Apr2016, Vol. 22 Issue 2, p451; Subject Term: CLINICAL trials; Subject Term: CLINICAL medicine -- Research; Subject Term: MEDICAL research; Subject Term: DATABASES; Subject Term: EUROPE; Author-Supplied Keyword: Clinical Trial Application; Author-Supplied Keyword: Europe; Author-Supplied Keyword: Harmonisation; Author-Supplied Keyword: Regulatory; NAICS/Industry Codes: 541712 Research and Development in the Physical, Engineering, and Life Sciences (except Biotechnology); Number of Pages: 16p; Document Type: Article
DOI10.1007/s11948-015-9662-0

Discipline: 

Subject: 

Publication: