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 main contents presented and discussed during the General Assembly meeting are summarized below.

Session I – Pharmacokinetic evaluations

The meeting opened with the presentation of the pharmacokinetic (PK) study results (DEEP-1 trial) in terms of study design, trial conduction, objectives and endpoints, the key features of a model-based approach, the comparison among existing PK data related to the administration of deferiprone and the role of the pharmacokinetic evaluation in the DEEP-2 study. Moreover, it was highlighted the step-by-step procedure and recommendations for the collection, handling and storage of the samples for the PK evaluation.

Session II – Statistics and economics

This session represented an overview of the statistical approach and handling of data applied within the DEEP-2 study as well as of the results obtained from the non inferiority assessment of deferiprone (DFP) in comparison with deferasirox (DFX). The pharmaco-economic study aimed to provide an Health Technology Assessment (HTA) evaluation on the use of deferiprone formulation in paediatrics, was also presented, with a focus on the preliminary results collected thanks to the on-going survey in 6 centres (1 Cyprus, 1 Greece, 2 Italy, 1 UK and 1 Germany). The ultimate goal is to predict how a change in the mix of drugs used to treat iron overload in the paediatric population will affect the expenditure on healthcare in different settings.

Sessions III / IV – Open Meeting

On the occasion of the 6th DEEP General Assembly, the 3rd Open Meeting was held in order to foster and highlight the potential of the clinical research in Albania and underline the importance of the involvement in Networks and projects in a global context, to create synergies to spread excellence and attract European funding.

Contents of the Open Meeting are summarised in the “Special focus Open Meeting“.

Session V – Ethics Board Meeting

This session gave the chance to discuss the difficulties encountered in the authorisation process of the DEEP project, due to the lack of harmonised procedures among European Countries and even more among European and non-EU Countries, highlighting the principle that European ethical and legal rules should prevail over regional or local issues.

Session VI – Investigator Meeting/DEEP-2 The Safety-Efficacy Trial

The session was focused on the study conduct and protocol implementation; practical aspects, such as planning initial and monthly visits according to the protocol and  monitoring safety and efficacy of study drugs, were addressed. Experience of many European and non-European recruiting centres for DEEP-2 (Italy, Greece, Cyprus, Egypt and Turkey) were presented with respect to the study conduct, number of patients currently screened and enrolled in the trial, the forthcoming recruitment and specific problems, such as the consent and the assent form to be signed in specific situations.

Session VII – DEEP-2 Emerging issues  

This session was focused on the open issues addressed and still to be dealt with, related to the study authorization and approval and the slowness of regulatory approval, the achievement of the study population size, Good Clinical Practice (GCP) and protocol compliance, as well as drug supply at the end of the trial. It was an important occasion to discuss about the state of the art of the DEEP-2 study and to present the new clinical sites included in the DEEP project in Morocco, Turkey and Lebanon to ensure the achievement of the study population size, and the consistency of the new patient recruitment plan with the expectation of patients to be enrolled (344) according to the Protocol.

Session VIII – DEEP-2 CRAs Training

Monitors involved in the DEEP-2 study was trained to perform a correct and standardized site visit report and to collect and transmit study documents, as part of monitoring activities to be performed at each clinical site. A specific session about critical issues raised during the monitoring activities and their correct handling was performed in order to guide monitors’ actions in specific critical situations. In particular, the session was the occasion to standardize the monitoring activities at each site involved in the study, in order to ensure high quality of clinical research and respect of patients’ rights and guarantee patients’ safety at the highest level.

Session IX – DEEP-3 Long-term safety study

The session opened with an overview of DEEP-3 study, including the patients distribution by centre and the detailed recruitment status. It was also highlighted the experience of the Paediatric Haematology of the Cairo University from the preliminary data screening to the approval pathway, the collection of data responding to the study inclusion criteria and the main challenges faced. In order to optimise the recruitment, it was proposed to include further two centres in Egypt which are already involved in DEEP-2 (Alexandria and Zagazig), to involve Turkish and Moroccan new sites  and to strengthen the recruitment efforts in Cyprus and Greece.

Session X – DEEP General Assembly

The status of the DEEP project in terms of deliverables, milestones, reports and budget as well as next steps and timelines was presented during the last session, in particular in light of the project review committed by the European Commission. The importance of the dissemination activities to raise awareness of the project, its activities and outcomes as well as to communicate results in peer-reviewed scientific journals and to lay media was also highlighted.

The meeting represented an excellent opportunity to foster fruitful scientific debates and networking, by providing a great opportunity for exchanging information, while discussing advancement in the work packages and partners’ involvement.

All the presentations of the 6^th General Assembly meeting can be downloaded from the dedicated page.

It is promoted by Consorzio per Valutazioni Biologiche e Farmacologiche (CVBF) in collaboration with University Hospital Center “Mother Teresa” (UHCT) and is organised in the framework of the DEEP project.

The Meeting will be the occasion to raise the attention on the progresses achieved by the clinical research in Albania and the importance of the European Networks to create synergies to spread excellence and attract European funding and entails two thematic sessions:

1.Clinical Research in Albania

2.Networks and Projects in a global context

The Meeting is accredited by QKEV and provides with 5 CME credits for Continuing education for healthcare professionals.

All sessions will be in English but simultaneous Translation English /Albanian will be available.

The Open Meeting is foreseen in the framework of the 6th DEEP General Assembly that will take place from the 18th to the 20th of May, 2015 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 the DEEP-2 Investigators’ Meeting, where a specific CRAs’ training session and individual training sessions on GCP, e-CRF and drug management will be available.

More details on the event and the related agenda are available here.

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.