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.

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.

In such a scenario, “the development of a tailored oral chelator for children”- as explained by Prof. Ceci – “responds to a still unmet need in the treatment of haemoglobinopathies, including thalassaemia, which require chronic blood transfusions and, therefore, iron chelation”.

Prof. Della Pasqua clarified the innovative approaches, implemented to overcome sensitive issues and ethical concerns about the conduct of trials in small children, which have led to the development of a Pharmacokinetic study aimed at determining the appropriate dosing requirements in children below six years of age.

The achievement of the project objectives, as explained by Dr. Bonifazi, was made possible thanks to the joint collaboration of experts in the field of thalassaemia, haematology, paediatric clinical trial design and management, regulatory and ethics, who gathered together to form a network of research institutions, clinical centres and patients associations from both European and non-European countries.

In conclusion, Prof. El Beshlawy highlighted that, as reported by a recent cost-utility analysis “deferiprone still represents the most cost-effective treatment available for managing chronic iron overload patients”, if compared to the other available chelators, thus resulting in a more easily accessible, safe and efficacious treatment with substantial cost savings for health services.

The European Commission featured the DEEP Project in Issue #34 of the research*eu results magazine. With Prof. Ceci answering the editorial staff’s questions, the article focuses on the achievements of the project studies in the past three years, which led to a new formulation of deferiprone with a better taste suitable for children, as well as valuable data on the correct dosage to be administered for each age group.

The lessons learned so far? ‘The project takes advantage of the participation of private pharmaceutical companies experienced in developing medicinal products and making them available on the market. Without such collaboration it would be unlikely that the drug would be distributed to all children in need. The lesson learned is that public and private efforts should (and can) be brought together to address the patients’ best interest.’

The magazine can be found online here, and this specific issue can be downloaded here.

research*eu results features highlights from the most exciting EU-funded research and development projects. It is published 10 times per year in English, and covers:

•    Biology and medicine
•    Social sciences and humanities
•    Energy and transport
•    Environment and society
•    IT and telecommunications
•    Industrial technologies
•    Space

An interview with Scientific Coordinator Professor Adriana Ceci was published with the title “Talassemia: farmaci a misura di bambino” on May 20, 2013 on the web portal Ricerca&Medicina, dedicated to Italian medicine projects funded under the Seventh Framework Programme of the EU with the aim to raise awareness on the project objectives and activities.