Mattia Zaffaroni, Maria Giulia Vincini, Stefano Arcangeli, Alessandra Cocchi, Agostina De Stefani, Andrea Riccardo Filippi, Davide Franceschini, Micaela Motta, Federica Piccolo, Davide Tomasini, Barbara Alicja Jereczek-Fossa, Antonio Laudati, Daniela Alterio
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引用次数: 0
Abstract
Background: 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.
Purpose: 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.
Methods: 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.
Results: 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.
Conclusion: While the RT centers in Lombardy demonstrate a commendable commitment to clinical research, disparities in resources and infrastructure remain significantly challenging.
背景：科研活动是提高医学知识的基础。在临床肿瘤学的背景下，放射治疗（RT）代表了治疗意图患者的基石。目的：本快照的目的是调查伦巴第（意大利）RT部门目前正在进行的临床试验的数量和特征，突出涉及的资源和改进研究激活过程的最终需求。方法：2024年4月，对伦巴第30个RT中心提出了一项由两部分组成的调查，即临床和研究活动的快照和正在进行的临床试验数据的数据库报告。快照由19个简短的回答问题组成。结果：26个中心（87%）接受了调查。正在进行的研究总数为161项。主要研究人员的平均年龄为51岁。大多数研究是多中心的（61%），全国的（76%）。在72项可用期研究中，43%为III期研究。53项（33%）研究得到资助。IRCCS （instituti di Ricovero e Cura a caratere scientifico）中位数为11项活跃研究，而非IRCCS结构中位数为6项。与非IRCCS中心相比，IRCCS中心可获得的资源更多：数据管理服务50%比25%，专门的科学护士20%比0%，临床统计服务60%比25%。开展临床试验的主要困难是伦理委员会（5个中心）的官僚主义困难、时间限制（5个中心）以及缺乏资源和人员（15个中心）。最常见的解决方案（58%的中心）是增加资源和人员。结论：虽然伦巴第的放射治疗中心在临床研究方面表现出值得赞扬的承诺，但资源和基础设施方面的差距仍然具有重大挑战性。
期刊介绍：
Clinical and Translational Oncology is an international journal devoted to fostering interaction between experimental and clinical oncology. It covers all aspects of research on cancer, from the more basic discoveries dealing with both cell and molecular biology of tumour cells, to the most advanced clinical assays of conventional and new drugs. In addition, the journal has a strong commitment to facilitating the transfer of knowledge from the basic laboratory to the clinical practice, with the publication of educational series devoted to closing the gap between molecular and clinical oncologists. Molecular biology of tumours, identification of new targets for cancer therapy, and new technologies for research and treatment of cancer are the major themes covered by the educational series. Full research articles on a broad spectrum of subjects, including the molecular and cellular bases of disease, aetiology, pathophysiology, pathology, epidemiology, clinical features, and the diagnosis, prognosis and treatment of cancer, will be considered for publication.
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