They have highlighted the progresses achieved by the clinical research in Albania so far and the importance of a more tight international collaboration within the European Networks to create synergies to spread excellence and attract European funding.

In particular, Donato Bonifazi explained that the DEEP-2 Safety/Efficacy Study represents the first paediatric clinical trial ever performed in Albania, currently enrolling patients. Beyond the administrative management of the study, the Italian Sponsor is extensively supporting the Albanian study team both in the start-up phase and in the trial progression, ensuring the performance of the trial in compliance to the ICH GCP. This represents a valid example of how to respond to European Commission (EC) Research policies promoting networking and public-private partnership, providing a new model for clinical research and disseminating competencies and technologies in non-European Countries.

The model proposed by DEEP focuses on therapeutic needs in paediatric and the integration of research and culture, adopting a global regulatory framework and patient-tailored transparent communication tools and has to become an example and the first milestone in developing the clinical research in Albania.

The videos of their interviews are available at the DEEP YouTube channel.

Particularly, QuBo will foresee the filling in of a an age-tailored structured questionnaire (one for 6-11 years old patients and another one for 11-18 patients) that will be used to directly collect the children’s and adolescents’ opinion on the DEEP-2 informative material.

The study will involve centres adhering to DEEP-2 and all patients receiving the DEEP-2 informative material, who will not undergo any other intervention, treatment, visit or procedure besides the ones belonging to the standard clinical practice. Children will only be asked to provide their feedback about the age-appropriate informative documents produced to explain key aspects of the clinical study.

The study is coordinated by Dr. Lorella Pitrolo, medical director at Unità Operativa di Pediatria –servizio Talassemia of the hospital Villa Sofia Cervello, Palermo, coordinating centre of the study. It has been approved in Albania and Italy and will soon involve other centres on a voluntary base.

The interviews offer an interesting picture of what the clinical research in Albania has achieved so far and what its legacy will be, in particular in light of a more tight international collaboration within a European research Network, as the DEEP project is.

Massimo Gaiani, Italian ambassador to Albania, opened the interview pointing out the importance of developing strong ties and networks as well as fostering the international cooperation to tackle the competition both at EU and global level.

At this YouTube channel, you can download Massimo Gaiani interview.

Amal El Beshlawy, Professor of Paediatric Hematology at Cairo University (Egypt) and President of the Egyptian Thalassemia Association talked about the cooperation between the EU and the Mediterranean countries, emphasizing the great results achieved in iron chelation therapy using deferiprone.

At this YouTube channel, you can download Amal El Beshlawy interview.

Vitangelo Dattoli, General Director of University Hospital Polyclinic of Bari (Italy), highlighted the success of the collaborative efforts in medicine and research between the two University Hospital Centres: “Mother Teresa” (UHCT) and Polyclinic of Bari.

At this YouTube channel, you can download Vitangelo Dattoli interview.

Etleva Refatllari from University Hospital Center “Mother Teresa” of Tirana (Albania) shared her experience in applying Good Laboratory Standards in a context characterized by the absence of any comprehensive guidance from regulatory and monitoring authorities.

At this YouTube channel, you can download Etleva Refatllari interview.

Gjeorgjina Kuli-Lito, Professor of Paediatrics at the University of Medicine, University Hospital Center “Mother Teresa” (UHCT) presented the critical issues in developing pediatric trials and the main points to be considered to ensure that a clinical trial could be successful.

At this YouTube channel, you can download Gjeorgjina Kuli-Lito interview.

Anila Godo, Professor of Paediatrics and Head of Onco-Haematology Service at the University Hospital Center “Mother Teresa” (UHCT), talked about the solid partnership between Albania and the DEEP consortium, focusing on the positive impact that the project brought to the Albanian pediatric research and on the importance of unifying diagnostic, preventive and therapeutic strategies at international level.

At this YouTube channel, you can download Anila Godo interview.

This event represents an important step both for the study, with the recruitment of the first paediatric patients in Albania in a not-for-profit study, but also for the patients themselves, having the chance to be undergone to a diagnostic procedure, which is, today, deemed necessary from major European guidelines and not currently available in-house.

The Scientific Conference was officially opened by the Chief Executive Officer of CVBF Albania, Donato Bonifazi, the Mayor, Fatos Tushe and the General Secretary of the “Associazione TALASSEMICI”, Mura Zenelaj.

The event was promoted by Consorzio per Valutazioni Biologiche e Farmacologiche (CVBF), Branch of Albania in collaboration with Università Cattolica “Nostra Signora del Buon Consiglio” of Tirana, a private university whose academic activities are implemented in collaboration with important Italian Universities (University of Bari “Aldo Moro”, University of Rome “Tor Vergata”, University of Milan, University of Bologna, University of Palermo, Catholic University of Milan).

On that occasion, the poster of the DEEP project was presented.

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

To download the presentations of the scientific conference:

– D. Bonifazi, Consorzio per Valutazioni Biologiche e Farmacologiche

– A. Zaka, Dita nderkombetare e luftes kunder Talasemise (in Albanian)

– A. Ceci, M. Kreka, Nuove terapie farmacologiche nella talassemia

– G. Adorno, La terapia trasfusionale nella talassemia

– F. Brancati, La genetica della talassemia

– N. Capodicasa, La donazione volontaria del sangue

DEEP-2 is, at today, the first paediatric clinical trial conducted in Albania; for this reason Consorzio per Valutazioni Biologiche e Farmacologiche (CVBF) in collaboration with University Hospital Center “Mother Teresa” (UHCT) has selected the city of Tirana as venue for the 3^rd edition of the DEEP Open Meeting.

The event represented 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. The meeting was accredited by the Albanian National Centre of Continuing Education, QKEV (providing with 5 CME credits of Continuing Education for healthcare professionals) and was structured into 2 thematic sessions focused on the Clinical Research in Albania and Networks and Projects in a Global Context, respectively. All sessions were carried out in English, with simultaneous translation English/Albanian available.

The meeting was opened by Anila Godo, Professor of Paediatrics at University Hospital Center “Mother Teresa” and Head of Onco-Haematology Service (Tirana), Donato Bonifazi, CEO of Consorzio per Biologiche Valutazioni e Farmacologiche and Ogerta Manastirliu, General Director of University Hospital Center “Mother Teresa” of Tirana.

The main contents presented and discussed during the Open Meeting are summarized below.

SESSION I – Clinical Research in Albania

The first session of the Open Meeting represented an opportunity for both European and Albanian key opinion leaders and experts to share their experiences in the field of paediatric clinical research. This session was, indeed, an occasion to discuss about many topics related to the conduction of paediatric clinical trials such as the barriers that researchers encounter to the timely development of safe and efficacious medicines especially for children, the related need to set up infrastructures for each study in each site, the collaborative efforts in medicine and research.
In particular, it was stressed the importance of the international cooperation in the activities performed in clinical research as a way to encourage interdisciplinary participation in developing solutions through high-impact, mission-driven collaborations with leading health providers, governments and educational institutions. In this way, the identification of the essential profiles involved in the concrete conduction of clinical research will be supported by the sharing of an high-quality and effective know-how, starting from the basis up to high specialisations proficiency.

The theme of clinical research was also addressed in light of the recent release of the Albanian Law on Drugs and Pharmaceutical services (31st July, 2014), and with a particular focus on the role of Albanian Universities in supporting clinical research as well as the achievements and challenges of the Continuing Medical Education.

Among the various Albanian personalities who attended the meeting, Prof. G. Kuli-Lito on behalf of the University Hospital Center “Mother Teresa”; the General Director of Health Policy and Planning, G. Bejtja, on behalf of the Albanian Ministry of Health and E. Shehu, Director of National Center of Continuing Education of Tirana.

SESSION II – Networks and Projects in a Global Context

The second session of the DEEP Open Meeting was focused on the importance of the Networks and Projects in a global context and on their impact on clinical research in paediatrics.

Among the several initiatives described at European and global level to promote paediatric research and reduce the extent of the off-label use, a special focus was dedicated to the experience of the University Hospital Center “Mother Teresa” (UHCT) in two EU-funded projects, in which it is involved as partner: the DEEP (DEferiprone Evaluation in Paediatrics) project and in particular the DEEP-2 Study and the GAPP (GAbapentin in Paediatric Pain) project. The international activities promoted in the clinical research field and in collaboration with an international research consortium will, indeed, provide support for aligning Albanian standards and practices with those present in the European Union for establishing working procedures to make innovation feasible.

An important example of European collaboration was also provided by the proposal of a new European Research Infrastructure for Paediatric Clinical Trials (EPCT-RI), as a new instrument identified in the European Research Agenda with reference to facilities, resources and related services used by the scientific community to conduct top-level research in their respective field.

Here you can download all the presentations of the Open Meeting.

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

The Scientific Conference will be officially opened by the Chief Executive Officer of CVBF Albania, Donato Bonifazi, the Mayor, Fatos Tushe and the General Secretary of the “Associazione TALASSEMICI”, Mura Zenelaj.

The event is promoted by Consorzio per Valutazioni Biologiche e Farmacologiche, Branch of Albania in collaboration with Università Cattolica “Nostra Signora del Buon Consiglio” of Tirana, a private university whose academic activities are implemented in collaboration with important Italian Universities (University of Bari “Aldo Moro”, University of Rome “Tor Vergata”, University of Milan, University of Bologna, University of Palermo, Catholic University of Milan).

On that occasion, the poster of the DEEP project will be presented.

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.