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.
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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.
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