The Italian Medicines Agency (AIFA) announced the conclusion of the double-stage selection process for the AIFA 2016 call. Among the 343 clinical protocols submitted and considered eligible, 40 projects have been approved for a total value of funding of € 31,294,724. CVBF will take part to 2 of the funded clinical studies.The PROMISE project is a multi-centre, randomised, open label pragmatic trial to compare the effectiveness and safety of interferon-beta 1a (IFN-beta 1a) weekly i.m. and glatiramer-acetate (GA) in paediatric patients affected by multiple sclerosis, coordinated by Prof. Lucia Margari of the University of Bari ‘Aldo Moro’ –University Hospital Policlinico of Bari. CVBF and the Italian network for Paediatric Clinical Trial (INCiPiT) to whom CVBF adheres, will provide several services within this project such as: identification of possible additional centres to meet the recruitment plan, support for Ethics approval and Competent Authority authorisation, preparation of the monitoring plan and performing of monitoring activities, data collection and analysis and any other requirements for clinical trials in accordance with Good Clinical Practice (GCP).
The OSequIT project is a multi-centre randomized clinical trial to compare the safety and efficacy of Deferasirox and Deferiprone administrated in sequential mode versus Deferasirox or Deferiprone in monotherapy in patients affected by Thalassemia Major, coordinated by Dr. Angela Vitrano and Prof. Aurelio Maggio of “Franco and Piera Cutino” Foundation in Palermo. In the framework of the project, CVBF will provide support for Ethics approval and Competent Authority authorisation; monitoring activities; clinical study reporting; pharmacovigilance activities.