On October 30th, 2015, the DEEP experience has been presented in Naples at the 37° Congress of the Italian Society of Pharmacology (SIF) by Dr. Viviana Giannuzzi from Gianni Benzi Pharmacological Research Foundation (FGB). The work, entitled “Ethical issues and barriers for multi-national paediatric clinical trials: the challenging experience of the DEEP project” and written by V. Giannuzzi, H. Devlieger, G. Papanikolaou, L. Ragab, R. Giuliani, B. Pantaleo, D. Bonifazi, A. Ceci on behalf of DEEP consortium, showed the main ethical issues surrounding the DEEP-2 trial, due to a lack of harmonization of procedures and requirements to set up and submit clinical trials to Ethics Committees and/or Competent Authorities.
Moreover, Dr. Giannuzzi highlighted how this lack of harmonisation makes more difficult the approach in case of studies involving non-EU Countries, as DEEP, and especially ‘small populations’, such as children and patients affected by rare diseases, which typically are multi-centre and multi-national.
More details on the event and the list of all submitted abstracts are available here.
