The impact of the new European CTR on academic clinical research: A survey by the Italian Sarcoma Group Federated Trial Centre

Abstract

Objective:

The Clinical Trials Regulation EU 536/2014 (CTR) has presented challenges for adapting experimental centres. To address this regulatory change, in 2023, the Italian Sarcoma Group (ISG) established a Federated Trial Centre (FTC) model, including Clinical Research Coordinators (CRCs) and Research Nurses (RNs).

Methods:

To explore the CTR’s impact, a 40-question survey was launched in April 2023, distributed among 48 FTC members from 27 Italian institutions, with 30 responding.

Results:

46.6% of responders reported the progress of their institutions in adapting to the regulation, 70% had good knowledge of the updates, 60% confirmed staff training on the CTIS (Clinical Trials Information System). However, 63.3% noted that administrative personnel were not aligned with new contract deadlines, and only in 26.6% of cases institutions offered CTR-specific training. Additionally, 53.4% expressed concerns that the CTR does not support academic research.

Conclusion:

The ISG’s FTC model was assessed as promoting collaboration between clinicians, staff, and CRCs to improve the management of academic studies and raise awareness within the sarcoma research community, by defining roles for CRCs and RNs and proposing collaborative projects and meetings.