This year the Scientific Open Meeting will  take its cue from the advancement in paediatric clinical research to address patients needs and will entail the following two thematic sessions:

 –          Challenges And Opportunities Of Conducting Clinical Trials In Paediatrics

–          Management Of Thalassaemia And Haemoglobinopathies: An Ongoing Challenge

The Open Meeting will be the occasion to raise the attention on the progresses achieved by the clinical research and the challenges to be faced in conducting clinical trials in paediatrics, also highlighting the importance of the international cooperation through European Networks and the global initiatives to create synergies and foster clinical research. The second session will be more focused on the new pathways and therapeutic strategies for the management of thalassaemia and haemoglobinopathies and will also be the occasion to talk about the goals of the DEEP project.

In particular, the Open Meeting will be the occasion to discuss these topics and challenges by different stakeholders points of views.

More details on the event and the final agenda are available here and through our social network channels (Facebook and Google+).

After the sad decision to cancel the General Assembly Meeting in Tunis, due to the disorders which have occurred across the country, the 7th DEEP General Assembly (GA) will take place in Padua (Italy) on April 13th -15th, 2016 with the participation of the whole DEEP Consortium as well as of external experts.

Here you can find the final agenda of the Meeting, which can be browsed even through mobile devices.

The meeting will be focused on a general update of the project’s activities, the progresses and achievements of the DEEP project as well as the finalization of the DEEP-2 and DEEP-3 studies, that are of utmost priority. Among others, the financial resources reallocation according to the recruitment performance at any involved centre will be discussed during the meeting.

In the same context of the GA meeting, the DEEP-2 Investigator Meeting and the 4th Open Meeting will take place.

In particular, the Scientific Open Meeting on April 15th, 2016 will entail two sessions:

   –  Challenges And Opportunities Of Conducting Clinical Trials In Paediatrics

   –  Management Of Thalassaemia And Haemoglobinopathies: An Ongoing Challenge

The Scientific Open Meeting will be the occasion to raise the attention on the progresses achieved by the clinical research and the challenges to be faced in conducting clinical trials in paediatrics, also highlighting the importance of the international cooperation through European Networks and the global initiatives to create synergies and foster clinical research. The second session will be more focused on the new pathways and therapeutic strategies for the management of thalassaemia and haemoglobinopathies and will also be the occasion to talk about the goals of the DEEP project.

More details on the event and the final agenda are available here and through our social network channels (Facebook and Google+).

The choice to select Tunis as venue for the next General Assembly comes from the willingness to raise awareness on the recruiting centres that are the backbone of the recruitment activities and to focus the attention on the Mediterranean region, in line with the Horizon 2020 strategy aimed at strengthening the cooperation with the Mediterranean area through the promotion of joint research projects in the health field in order to promote the development and the Mediterranean integrity itself.

The meeting will be the occasion to talk about the goals and the progress of the project and its contribution to improving of the clinical management of children with transfusion-dependent thalaessemia and other hemoglobinopathies who need chelation therapy.

Tunis will also be the venue to 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.

More details on the event and the related agenda will be soon available through our social network channels (Facebook and Google+).

The 6th DEEP General Assembly will take place from the 18th to the 20th of May, 2015 in Tirana (Albania), with the participation of the whole DEEP Consortium as well as of external experts. The General Assembly will also host  the fourth Ethics Board meeting and two open meeting sessions (Clinical Research in Albania and Networks and Projects in a Global Context) with the participation of international prominent personalities in the field of clinical research. The DEEP-2 Investigators’ Meeting, a specific CRAs’ training session and individual training sessions on GCP, e-CRF and drug management will be available during the Meeting.

DEEP is the first clinical trial in which the University Hospital Centre “Mother Teresa” of Tirana (which represents the main and most important Albanian Hospital) is officially involved, after the entry into force of the new Albanian law concerning clinical trials (which took place in July 2014), and forthcoming implementation decrees.

The inclusion of Albania in the DEEP study represents an important milestone for a country that is currently managing its first non-profit paediatric trials. This will pave the way towards a new era for clinical research in Albania to the heightening of the quality of the clinical research in Albanian public institutes.

More details on the event and the related agenda will be soon available.

The 5^th DEEP General Assembly took place from the 3^rd to the 5^th of July 2014 in the legendary city of Athens, Greece, with the participation of the whole DEEP Consortium as well as external experts. The main contents presented and discussed are summarized below.

Session I: DEEP-1 Results
The meeting opened with the presentation of the results of the pharmacokinetic study (DEEP-1 trial) and their impact on the DEEP-2 study conduct. The collected data provide valuable information on the correct dosage of deferiprone to be administered to children below 6 years of age. Although multicentre trials are particularly difficult for PK evaluations, the team congratulates the investigators and all the study staff as data collected within DEEP-1 are excellent.

Session II: Organization of the DEEP-2 Trial
The DEEP-2 trial implementation, in terms of authorisation process and status, IMPs distribution, technical facilities was discussed. Moreover, the psychological sub-study to investigate parents’ behaviour during the DEEP-2 recruitment phase was presented. The main questions and queries arisen during the first weeks of recruitment were discussed and common actions/solutions were shared and agreed upon and included in the DEEP-2 FAQ.

Session III: DEEP-2 Recruiting Centres
The importance to adopt proper communication strategies and flows between the Sponsor’s staff and Investigators’ team, even when face-to-face interactions are not possible, was stressed in order to guarantee the best management of each trial procedure. In particular, the monitoring procedures to be carried out were described and the experience of the already performed monitoring visits with the most challenging issues was shared.

Session IV: DEEP-3 Long Term Safety Study
After the presentation of the preliminary results and the criteria for Adverse Drug Reaction and Adverse Events assessment, the discussion focussed on the slow recruitment process observed so far. Strategies to accelerate recruitment were discussed. Sample size calculation based on the number of patients and patients’ age is proposed and will be conducted in the following weeks. Moreover it was clarified that any use of deferiprone both as monotherapy and in combination will deferoxamine is currently included in the protocol.

Scientific Open Session
The GA presented the opportunity to hold an open Scientific Meeting on July 5^th, which focussed on specific topics of interest in the field of iron chelators and iron overload where eminent scientists and experts provided an overview of:

– the new paediatric clinical trial regulation;

– the main features of deferiprone therapy, either alone or in combined regimen, in terms of safety, efficacy and significant clinical evidence in hepatic and cardiac iron overload;

– the management of iron overload in Sickle Cell Disease;

– the importance of Magnetic Resonance Imaging analysis;

– the new therapies for the treatment of Hepatitis C virus Infection.

The Sicilian Network for Thalassemia, established for the prevention, observation, diagnosis and therapy of thalassemia, is led by Ospedali Riuniti Villa Sofia – Cervello, who is one of the lead beneficiaries in the DEEP Project. The Network involves health-care facilities and acts with the aim to increase awareness and spread information on the social problem, maintain qualitative and quantitative thalassemia screening standards and develop pure research.

DEEP Project Manager Donato Bonifazi and DEEP Trial Coordinating Investigator Aurelio Maggio presented the project, illustrating its development and implementation. The “Thalassemia and Sickle-cell anaemia: pathologies projected into the future” conference followed in the afternoon and finally a new clinical centre for thalassemia was inaugurated.

Particular attention was paid to countries outside the European Community to ensure that standardised rules, compliant to the Directive 2001/20/EC, are followed. During the Investigator Meeting, all subject involved (Investigators, CRO, Pharmacovigilance Team) had the opportunity to meet and interact.

Some of the activities that were discussed during the meeting are:

•    Study visits and randomization procedures
•    CRF
•    Sponsor/Investigator responsibilities
•    Informed consent process