The DEEP Project review report, prepared by Dr. Plaseska-Karanfilsk (expert to the European Commission) has been sent out by the Project Officer, Mr Alexandru Sorin Costescu with a very positive evaluation about the project.
The report covers the period from 01/01/2011 (project start date) to 31/12/2013 and takes into consideration that DEEP, originally planned as a 4 year project, has faced three amendments of the Description of Work with prolongation of the project for 20 months. Although have produced delays in the start-up of the clinical studies and related tasks, these changes have been considered as highly justified and will improve the output and impact of the DEEP project. Indeed, the major delays in DEEP project during the last years were related to the requests of changes in the PIP and long lasting ethical approvals. So, now that the majority of centres have already received the approvals for the clinical trial it should be easier to continue with the related tasks.
It was particularly highlighted that the DEEP project has made sufficient progress and is ready to reach the goals and to contribute to the improvement of the clinical management of children with transfusion-dependent thalaessemia and other hemoglobinopathies who need chelation therapy. The whole project and the individual workpackages have been making satisfactory progress, as well as results of this study provide scientific evidence that the dosage of deferiprone used in adults can be effective also in small children.
Regarding the recruitment rate, Dr. Plaseska-Karanfilsk stressed that the measures undertaken by the Project Management Team (PMT) have been successful and that DEEP-2 and DEEP-3 studies have been recruiting patients with an increasing rate, ensuring that the objectives could be reached by the end of the project.
The expert continues encouraging the project Partners to strengthen the efforts towards recruiting increasing number of patients in the DEEP-2 and DEEP-3 studies in order to ensure finalization of these clinical studies which are very important for the overall success of the DEEP project.
One further positive evaluation was referred to the DEEP Consortium consisting of strategic partners with specific expertise in hemoglobinopathies and paediatric clinical trials design and managements, regulatory aspects and ethic issues. The complementarity has been well appreciated as regards to expertise and resources within DEEP Consortium and the balance achieved also with reference to geographical spread across the Mediterranean region with the highest incidence of thalassemias.
The report was concluded with a note regarding the dissemination activities and all Partners were inviting to publish the project results in peer reviewed papers.