(P 144) IMPLEMENTATION OF THE EUROPEAN CLINICAL TRIAL REGULATION: SURVEY OF THE ITALIAN SARCOMA GROUP CENTERS

Objective: The European Clinical Trials Regulation 536/2014 (CTR) entered into full application on January 31st 2022, by inducing a holistic revolution in European clinical trials (CTs) management. The CTR-related core change was the new Clinical Trials Information System (CTIS). CTIS represents a unique single-entry point for sponsors and authorities, to use for CTs submission and evaluation and includes a searchable database for healthcare professionals and general public. CTIS is an innovative tool that should simplify the submission of CTs application. In Italy, the implementation of CTR required several regulatory steps at national level and substantial procedural modifications at site level. The Italian sarcoma Group (ISG) has recently created a new federated trial center (FCT) organizational model aimed at promoting the establishment of an expert team in the conduction of clinical studies, to share experiences and expertise. Within this model the Study Coordinators of national reference centers for sarcomas belonging to ISG were also educated to the awareness about critical issues, such as CTR implementation, in academic clinical research environment in order to bridge a gap among institutions and sponsors. We herein report the results of a survey that has been circulated among Italian sites belonging to the ISG and aimed at investigating the compliance and the major challenges faced by affiliated sites in adapting to the CTR.

Methods: In April 2023, an anonymous online survey was distributed to the Study Coordinators of the ISG Federated Trial Center and remained active for 2 weeks. All data were anonymous, and participation was voluntary. The questionnaire included 5 macro-areas, with 40 questions overall, assessing institutional awareness and compliance for each item: internal site current organization, management of a new clinical trial submission, assessment of local feasibility, experience with CTIS portal use and future perspectives. Survey was designed with closed-ended questions including binary answers (yes/no), a-single-choice-option list, answers using an ordinal scale (1-10). These latter ones were used to investigate on self-assessments or capabilities of one’s facility and results were statistically analysed with mode and median. A cross-tabulation analysis was used to evaluate responses

Results: 30/48 sites (62,5%) completed the survey. 21/30 were more than sufficiently (conscious median=6.5; mode=7) about the changes introduced by CTR. 50% of responders (n= 15/30) declared that they autonomously found out the training useful for their preparation. 30 responders rated their sites ability to align with the new timeline, to obtain signed study agreement between sponsor and participating site, as not sufficient enough (median=5; mode=5). 25 out of 30 (83,3%) of the sites answered the CTIS related questions. The awareness rate of the new CTR procedures on drafting documentations was complete in 88% of the sites (n=22/25), whereas CTR details for anonymization of personally protected data and commercially confidential information in the clinical documents, requested for a public presentation in CTIS, was known by 72% (n=18/25). Moreover, 72% of responders (n=18/25) confirmed that a dedicated staff, was identified and specifically trained on CTIS use within their group, while other 16% (n=4/25) were going to plan to do so. On April 2023, 11/30 (36.6%) of participants had already submitted new studies through the CTIS and, in 10 of 11 (90.9%) the submission was accomplished by the in-house staff while in 1/11 was made by an external organization.

Conclusion: Our results showed that most of the research staff belonging to the Italian sarcoma centres have correctly acquired the CTR required skills. Moreover, Italian academic research can rely on its staff, which received high-profile training on CTIS use. This provides the background to the conduction of future academic studies, among which in particular the investigator-initiated ones that are involved in ISG projects. In conclusion an organisational model such the FCT of ISG can be considered as a possible way to support future academic research within the context of the new CTR.