In the early 2000s, the European directive on clinical trials brought in unnecessary administrative and regulatory burdens, with negative effects in particular for academic research. The increased bureaucratic complexity and associated costs made the approval and management processes of clinical trials significantly more challenging for a standard academic group.
To meet these new challenges, in Italy, hematology trial management was centralized in a unique organization, the GIMEMA Foundation, a “spin off” of the Data Center of the Hematology Department at Sapienza University of Rome. The organization is structured with(a) Working Parties, each focused on a different hematological disease or task and including the top Italian experts in each field to propose and evaluate new ideas for academic trials and (b) a Central Office named the Data Center, charged with performing all research activities according to national and international rules and procedures on clinical trials.
The main activities carried out by the Data Center include protocol design and development - from clinical hypothesis to statistical assessment, regulatory affairs management, pharmacovigilance, statistical analysis, scientific writing, and training in clinical trials activities.
To comply with international standards of Good Clinical Practice (GCP), the Data Center developed a series of internal standard operating procedures (SOP) obtaining in 2002, the UNI EN ISO 9001:2000 certification for the activities of the “Design, implementation and management of clinical trials.” Since 2015, the Data Center is also a Certified ECRIN Data Centre.
As a centralized organization, GIMEMA is well equipped to run several multi-center national and international clinical trials, leading to new indications for diagnosis and treatment of hematological malignancies.