中心有无协调员?作为研究团队重要组成部分的协调员

IF 1.4 Q4 MEDICINE, RESEARCH & EXPERIMENTAL Open Access Journal of Clinical Trials Pub Date : 2024-05-01 DOI:10.2147/oajct.s462674
Izabela Gudewicz, Justyna Hajtuch, Renata Zaucha
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引用次数: 0

摘要

:整个临床试验过程是一个完美的团队。多年后,各中心才开始聘用临床试验协调员。决定这样做的中心不仅从研究的技术方面注意到了积极的方面,而且从参与者(即患者)方面也注意到了积极的方面。该出版物的目的是收集文献数据,说明协调员在各中心的工作及其对提高研究效率的影响。比较还包括协调人的角色对患者招募和认知的重要性。所分析的中心显示,协调员对其中心研究的影响约为中国为 99.1%(对患者权利的了解),意大利为 80%(提高了临床试验的质量),韩国为 70%(对减少患者撤销同意的影响)。没有协调员支持的团队在患者中获得的信任较少,这影响了参与者的招募和保留。协调员对研究管理的影响使研究组织得更好。所得出的结论可为中心的发展,进而为世界各地的临床试验提供支持。聘用协调员不仅能改善研究管理,还能增加纳入研究的患者人数,从而增加医学治疗方案。本文旨在对有关临床试验协调员职责的现有文献进行梳理,进而倡导他们为提高临床试验的疗效和效率所带来的价值。
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Center with or Without a Coordinator? The Coordinator as an Integral Part of a Research Team
: The entire clinical trial process is a perfectly orchestrated team. It took many years before centers started hiring clinical trial coordinators. The centers that decided to do so noted not only positive aspects from the technical side of the study, but also from the side of the participants - which are the patients. The aim of the publication was to collect literature data showing the work of the coordinator in the centers and its impact on increasing the effectiveness of the study. The comparison additionally included the importance of the coordinator’s role on patient recruitment and perceptions. The centers analyzed, showed the impact of the coordinator on their center’s research at approximately: 99.1% in China (knowledge of patient rights), 80% in Italy (increasing the quality of the clinical trial conducted) and 70% in South Korea (impact on reducing patient withdrawal of consent). Those teams that worked without the support of a coordinator gained less trust among patients, which affected recruitment and retention of participants. The coordinator’s influence on study management resulted in better organization of the study. Conclusions reached can support the development of centers and thus clinical trials around the world. Hiring a coordinator not only has an impact on improving the management of the study, but also on increasing the number of patients included, and thus increasing the therapeutic options in medicine. This paper aims to compile existing literature concerning the responsibilities of clinical trial coordinators and subsequently advocate for the value they bring to enhancing the efficacy and efficiency of clinical trials.
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来源期刊
Open Access Journal of Clinical Trials
Open Access Journal of Clinical Trials MEDICINE, RESEARCH & EXPERIMENTAL-
CiteScore
3.90
自引率
0.00%
发文量
2
审稿时长
16 weeks
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