This year, the 6th DEEP General Assembly (GA) took place from the 18th to the 20th of May, 2015 in Tirana (Hotel Tirana International, Albania) with the participation of the whole DEEP Consortium as well as external experts. The General Assembly also hosted 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. Particular attention was paid to the training of the key figures involved in the clinical trials and a specific CRAs’ training session was organised during the DEEP-2 Investigator Meeting as well as individual training sessions on GCP, e-CRF and drug management were available during the 3-day meeting.
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 6th General Assembly meeting can be downloaded from the dedicated page.
