In particular, CRAs and PIs highlighted the strengths and weaknesses encountered in the study conduction with particular reference to the following issues:

• Informed consent procedure

• Planning study visits

• IMPs handling

• Dose adjustments for Safety and Efficacy reasons

• Periodic assessments for Safety

• Data entry in e-CRF

• Collection of Ferritin Samples for centralized evaluations and MRI Scans

• Study documentation

• Pharmacovigilance

• Monitoring activities.

The gathered information have provided updated information on all the centres involved in the study and are essential to identify the main issues to be solved to increase the effectiveness of the study and to ensure patients’ safety and high quality of collected data.

The last patients were included in Albania, Italy and UK while the 393rd patient has been randomized on 14/7/2016 in UK.

An important action carried out by the DEEP-2 Trial Management Team aimed at ensuring the correct implementation of the study protocol is the release of a monthly DEEP-2 study newsletter (available on the DEEP website in the Study Newsletter section), that is sent to all PIs and also available on the website, aimed at clarifying most of the criticisms of the study protocol.

Stay connected with the DEEP website and social networks (Facebook and Google+) to be updated.

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 DEEP-2 study will terminate when 388 patients will have been randomized. In order to meet this goal and allow newly activated centers to reach potential recruitment target, a further extension of enrollment has been granted until the end of April 2016. In this sense, a new center in Cyprus received the SIV on 26/02/2016 and is now ready to start the enrolment.

An important action carried out by the DEEP-2 Trial Management Team aimed at ensuring the correct implementation of study protocol is the release of a monthly DEEP-2 study newsletter (available on the DEEP website in the Study Newsletter section), that is sent to all PIs, with an update of the patients’ enrolment and the FAQ section, available on the website, aimed at clarifying most of the criticisms of the study protocol.

Stay connected with the DEEP website and social networks (Facebook and Google+) and look at the counter on the homepage to be updated on the DEEP-2 enrollment status!

The DEEP-2 study actually involves a total of 227 patients included in 32 recruiting centres: Italy (51), Egypt (123), Greece (9), Albania (25) Tunisia (7) and UK (10). The first nine patients have been enrolled in UK and 10 in Tunisia this week. The enrollment will terminate when 344 patients will have been randomized.

Further 5 new centres in Turkey (Hacettepe University, Faculty of Medicine in Ankara; Istanbul University, Cerrahpaşa Faculty of Medicine in Istanbul; Kanuni Sultan Suleyman TRH in Istanbul; Mersin University Faculty of Medicine in Mersin; Akdeniz University Medical Faculty in Antalya), 1 in Lebanon (Nini Hospital in Tripoli), 1 in Albania (Hospital ‘Ihsan Çabej’ in Lushnjë) and 1 in Qatar (National Center for Cancer Care and Research in Doha) have been contracted and are very close to recruit their first patients. The centers in Cyprus and Morocco are waiting for the last authorization before they can be activated.

In order to ensure the correct implementation of study protocol and speed up the recruitment phase, the DEEP Management Team has issued a new version (2.0) of the Study Procedure Manual both in PDF format and hard copy to be sent to each site. This version is specifically addressed to the clinical investigators aiming at facilitating consistency with protocol implementation among study sites and to be an on hand reference to solve doubts/questions that may arise during the study conduction.

Moreover, all PIs regularly receive a monthly DEEP-2 study newsletter with an update of the patients’ enrolment and the FAQ section, available on the website, aimed at clarifying most of the criticisms of the study protocol.

Stay connected with the DEEP website and social networks (Facebook and Google+) and look at the counter on the homepage to be updated on the DEEP-2 patients recruitment status!

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.

Principal Investigators (PIs) are still working to continue the enrollment of patients within the DEEP-2 study and to date a total of 117 patients have been already included in 12 recruiting centres: Italy (43), Egypt (53), Greece (6), Albania (15). Further 2 centers are very close to recruit their first patients and 10 recruiting centres are still waiting for receiving the approval/Site Initiation Visit. In order to be sure to reach the planned number of patients, 3 new centres in Turkey (Hacettepe University, Faculty of Medicine in Ankara; Istanbul University, Cerrahpaşa Faculty of Medicine in Istanbul; Kanuni Sultan Suleyman TRH in Istanbul), 1 in Lebanon (Nini Hospital in Tripoli), 1 in Albania (Hospital ‘Ihsan Çabej’, Lushnjë) and 1 in Qatar (National Center for Cancer Care and Research, Doha) are being activated.

Total number of centers will then be 30.

Stay connected with the DEEP website and discover the counter on the homepage to be updated on the DEEP-2 patients recruitment status!