Zaffaroni Mattia, Vincini Maria Giulia, Arcangeli Stefano, Cocchi Alessandra, De Stefani Agostina, Filippi Andrea Riccardo, Franceschini Davide, Motta Micaela, Piccolo Federica, Tomasini Davide, Jereczek-Fossa Barbara Alicja, Laudati Antonio, Alterio Daniela
Department of Radiation Oncology, IEO European Institute of Oncology IRCSS, Milan, Italy.
Department of Radiation Oncology, University of Milan Bicocca, Milan, Italy.
Clin Transl Oncol. 2025 Apr 21. doi: 10.1007/s12094-025-03919-9.
The research activity is fundamental to improve knowledge in Medicine. In the setting of clinical oncology, radiotherapy (RT) represents a cornerstone for patients treated with curative intent.
The aim of this snapshot was to investigate the number and the characteristics of clinical trials currently ongoing in the Lombardy (Italy) RT divisions highlighting involved resources and eventual needs to improve the process of study activation.
In April 2024, a survey composed of two parts, a snapshot of clinical and research activity and a database to report data on ongoing clinical trials, was proposed to the 30 RT centers in Lombardy. The snapshot consisted of 19 short answer questions.
A total of 26 (87%) centers answered the survey. The total number of active studies was 161. The median age among principal investigators was 51 years. Most studies were multicentric (61%) national (76%). Among 72 studies with available phase, 43% resulted phase III studies. Fifty-three (33%) studies were sponsored. IRCCS (Istituti di Ricovero e Cura a carattere scientifico) RT have a median of 11 active studies vs versus 6 in non-IRCCS structures. More resources are available in IRCCS centers compared to non-IRCCS: data management service 50% vs 25%, dedicated scientific nurses 20% vs 0%, clinical statistics services 60% vs 25%. The main difficulties in conducting clinical trials were bureaucratic difficulties with ethics committees (5 centers), time constraints (5 centers), and a lack of resources and staff (15 centers). The most frequently (58% of the centers) proposed solution was an increase in resources and staff.
While the RT centers in Lombardy demonstrate a commendable commitment to clinical research, disparities in resources and infrastructure remain significantly challenging.
研究活动对于增进医学知识至关重要。在临床肿瘤学领域，放射治疗（RT）是根治性治疗患者的基石。
本快照研究旨在调查意大利伦巴第地区目前正在进行的放射治疗部门临床试验的数量和特征，突出所涉及的资源以及改善研究启动过程的最终需求。
2024年4月，向伦巴第地区的30个放射治疗中心发放了一份由两部分组成的调查问卷，一部分是临床和研究活动的快照，另一部分是用于报告正在进行的临床试验数据的数据库。该快照由19个简答题组成。
共有26个（87%）中心回复了调查。活跃研究的总数为161项。主要研究者的中位年龄为51岁。大多数研究是多中心的（61%）、全国性的（76%）。在72项可获得阶段信息的研究中，43%为III期研究。53项（33%）研究有资助。IRCCS（科研性质的康复与治疗机构）放射治疗中心的活跃研究中位数为11项，而非IRCCS机构为6项。与非IRCCS中心相比，IRCCS中心有更多资源：数据管理服务分别为50%和25%，专职科研护士分别为20%和0%，临床统计服务分别为60%和25%。开展临床试验的主要困难包括与伦理委员会的官僚主义问题（5个中心）、时间限制（5个中心）以及资源和人员短缺（15个中心）。最常被提议的解决方案（58%的中心）是增加资源和人员。
虽然伦巴第地区的放射治疗中心在临床研究方面表现出值得称赞的投入，但资源和基础设施的差异仍然是重大挑战。
