The Proposal for an European Regulation on clinical trials, repealing the CT Directive 2001/20/EC, has received the first reading approval last May 29th by the ENVI EP Committee. Many advancements are expected by the new Regulation, including the creation of a public EU-wide database for all clinical trials with a single portal for Clinical Trial Applications and a mixed (centralised/decentralised) system of review and authorisation. Many criticisms have been put forward with reference to the following aspects:
− Ethical approval in all phases of the procedure (the ethical evaluation should be included not only in the national assessment but also in the centralised assessment)
− Transparency (many organisations required that trial outcomes should be published in the CT database within a year after their completion, and obligations if sponsors do not comply with this requirement).
− Special population protection (it should be recognised that patients with specific needs, like pregnant or breastfeeding women, persons deprived of liberty and people with specific needs should receive specific attention when subject of a trial)
− Paediatric aspects (the Proposal did not comply with the requirements of the Paediatric Regulation and the related Paediatric Ethical Recommendations – EC, 2008).
The Gianni Benzi Pharmacological Research Foundation participated in the debate opened in Europe and submitted some proposal of amendments on the above mentioned critical points (see document available below) and also collaborated with GRiP, the Global Research in Paediatrics EU-funded Network of Excellence to support the amendments aimed to implementation appropriated measures tailored for children in the new Regulation (for more information please visit http://www.gripnetwork.org/index.php/en/news/item/24). Many criticisms have been solved in the published compromised amendments. Nevertheless, we still underline that all the amendments dealing with the ethical protection of children have been rejected. The Gianni Benzi Foundation will continue its initiatives towards the Council and the Member States.