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

IF 2 4区医学 Q3 ONCOLOGY

Tumori Pub Date : 2025-06-01 Epub Date: 2025-04-10 DOI:10.1177/03008916251330093

Viviana Appolloni, Gianluca Ignazzi, Daniela Salvatore, Simone De Meo, Salvatore Vizzaccaro, Silvia Stacchiotti, Giacomo Giulio Baldi, Celeste Cagnazzo

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引用次数: 0

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.

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新的欧洲CTR对学术临床研究的影响：意大利肉瘤集团联邦试验中心的一项调查。

目的：临床试验法规EU 536/2014 （CTR）对适应实验中心提出了挑战。为了应对这一监管变化，2023年，意大利肉瘤集团（ISG）建立了联邦试验中心（FTC）模式，包括临床研究协调员（crc）和研究护士（rn）。方法：为了探讨CTR的影响，我们于2023年4月启动了一项包含40个问题的调查，调查对象是来自意大利27家机构的48名FTC成员，其中30人做出了回应。结果：46.6%的应答者反映其机构在适应法规方面取得了进展，70%的应答者了解最新的法规，60%的应答者确认对员工进行了CTIS（临床试验信息系统）培训。然而，63.3%的人指出，行政人员与新的合同期限不一致，只有26.6%的机构提供了专门的中心培训。此外，53.4%的受访者表示担心CTR不支持学术研究。结论：ISG的FTC模型被评估为促进临床医生、工作人员和crc之间的合作，通过定义crc和rn的角色，提出合作项目和会议，改善学术研究的管理，提高肉瘤研究界的认识。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Tumori 医学-肿瘤学

CiteScore

3.50

自引率

0.00%

发文量

审稿时长

6 months

期刊介绍： Tumori Journal covers all aspects of cancer science and clinical practice with a strong focus on prevention, translational medicine and clinically relevant reports. We invite the publication of randomized trials and reports on large, consecutive patient series that investigate the real impact of new techniques, drugs and devices inday-to-day clinical practice.