在德国一家由四所大学医院组成的联合综合癌症中心,引入了一种参与临床试验的新卫星模式。

IF 2 4区 医学 Q3 ONCOLOGY
Johanna Teloh-Benger, Susanne Isfort, Norbert Gattermann, Ingo G H Schmidt-Wolf, Martina Crysandt, Angelika Kötting, Annett Falkenhahn, Olivia Hardebeck, Kristoffer Lenssen, Alexander Werz, Alexandra Krüger, Thomas Zander
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引用次数: 0

摘要

简介个性化医疗的趋势导致临床试验的研究队列规模非常小,因此很难在一个研究中心招募患者。另一方面,启动临床试验所需的行政工作也非常繁重。因此,作为试验地点,德国面临着落后于其他国家的风险。因此,亚琛-波恩-科隆-杜塞尔多夫综合肿瘤中心(CIO ABCD)一直在努力挑战一种新的卫星模式,即只有主试验中心与申办者签订试验中心合同,并与申办者办理所有手续。其余地点构成卫星。与以前的卫星模式不同,在目前的模式下,与研究相关的所有干预措施都在每个研究点进行:为了评估该模式的可批准性,我们与上级联邦当局和主管监察部门进行了联系,但他们都没有声明自己对可能的基本批准负责。所联系的四个伦理委员会均同意该模式,但须满足某些框架条件。此外,还就各种问题(医疗、劳动、反垄断法)起草了若干法律意见,对该模式进行了验证:结论:就近参与研究对多病患者具有决定性的优势。在该模式中,一个试验点最多可由四个地点组成,因此可以在降低行政成本的情况下覆盖大片区域。所开发的卫星模式旨在让患者更广泛地获得癌症治疗方面的医疗创新。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Introduction of a New Satellite Model for Participation in Clinical Trials in a Consortial Comprehensive Cancer Center with Four University Hospitals in Germany.

Introduction: The trend toward personalized medicine leads to very small study cohorts for clinical trials, which makes it difficult to recruit patients in a single study center. On the other hand, the administrative effort required to initiate a clinical trial is very high. As a result, Germany runs the risk of falling behind other countries as a trial location. For this reason, the Center for Integrated Oncology Aachen Bonn Cologne Duesseldorf (CIO ABCD) has been working on the challenge of a new satellite model in which the main trial center is the only one to conclude a trial center contract with the sponsor and also handles all formalities with it. The remaining sites constitute the satellites. In contrast to former satellite models, the entire study-related interventions are carried out at each site in the present model.

Methods: In order to evaluate the approvability of the model, contact was made with both higher federal authorities and the responsible inspectorate, and none of them declared themselves responsible for a possible basic approval. The four ethics committees contacted agreed to the model subject to certain framework conditions. In addition, the model was validated by the preparation of several legal opinions on various issues (medical, labor, antitrust law).

Conclusion: Study participation close to home is a decisive advantage for multimorbid patients. As up to four locations form a trial site in the model, a large catchment area can be covered with reduced administrative costs. The satellite model developed is intended to give patients broader access to medical innovations in cancer therapy.

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来源期刊
CiteScore
3.20
自引率
0.00%
发文量
84
期刊介绍: With the first issue in 2014, the journal ''Onkologie'' has changed its title to ''Oncology Research and Treatment''. By this change, publisher and editor set the scene for the further development of this interdisciplinary journal. The English title makes it clear that the articles are published in English – a logical step for the journal, which is listed in all relevant international databases. For excellent manuscripts, a ''Fast Track'' was introduced: The review is carried out within 2 weeks; after acceptance the papers are published online within 14 days and immediately released as ''Editor’s Choice'' to provide the authors with maximum visibility of their results. Interesting case reports are published in the section ''Novel Insights from Clinical Practice'' which clearly highlights the scientific advances which the report presents.
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