After the sad decision to cancel the General Assembly (GA) meeting in Tunis, due to the disorders which have occurred across the Country, the 7th DEEP General Assembly was held in Padua, Italy between April 13th and 15th, 2016 with the participation of the whole DEEP Consortium as well as of external experts.
The meeting provided an update on the achievements and difficulties encountered toward the implementations of specific project tasks, the reasons for some delays and the mitigation strategies set into place in order to overcome such obstacles.
The meeting opened with a comprehensive overview of the activities performed and the most important achievements carried out, with particular reference to the implementation of the DEEP studies in compliance with the Paediatric Investigation Plan – PIP (EMEA-001126-PIP01-10), as approved and further amended by the Paediatric Committee (PDCO). In particular, the main efforts carried out to implement DEEP-2 recruitment and study conduct were highlighted, that have led to an increase of the number of clinical centres, the check of the recruitment capacity as well as the organisation of study qualification visits.
Moreover, an update of the clinical studies has been provided, with a particular focus on:
• the difficulties to conduct the DEEP-2 trial that has to face a default level of complexity, due to regulatory, methodological, ethical and administrative issues;
• the status of DEEP-3 Study and its updated results;
• the updated overview of the pharmaco-economic study.
Among others, the financial resources reallocation according to the recruitment performance at any involved centre have been discussed during the General Assembly meeting.
The second meeting day provided an update on DEEP-2 study protocol and procedures and was characterised by the organisation of the DEEP-2 Investigator Meeting, held as a guided roundtable where CRAs and Principal Investigators from main recruiting sites have presented and discussed the strengths and weaknesses of their own center.
In the same context of the GA meeting, the 4th Scientific Open Meeting took place on April 15th, entailing two sessions:
-Challenges and opportunities of conducting clinical trials in paediatrics
-Management of thalassaemia and haemoglobinopathies: an ongoing challenge
The meeting represented an excellent opportunity to foster fruitful scientific debates and exchange information. Advancement in the work packages and partner involvements were discussed in order to build a perfect working basis for the forthcoming activities.
All the presentations of the 7th General Assembly meeting can be downloaded from the “Presentations” dedicated page.
All the abstracts of the DEEP Open Meeting can be found in the dedicated brochure, which can be browsed even through mobile devices.