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试验管理:我们需要一批高素质的临床试验人员来提供患者所需的答案。

Trial management: we need a cadre of high-class triallists to deliver the answers that patients need.

机构信息

Clinical Trials Unit, Department of Population Health, London School of Hygiene and Tropical Medicine, Keppel Street, London, WC1E 7HT, UK.

出版信息

Trials. 2019 Jun 13;20(1):354. doi: 10.1186/s13063-019-3451-z.

Abstract

Expert trial managers with the training and experience to overcome operational challenges are often the difference between the success and failure of a clinical trial. Considerable importance is given to the beginning and the end of the clinical trial process, with those responsible for writing a protocol, obtaining funding and analysing the data all being rewarded when the results are published. Yet, trial managers are often overlooked in terms of recognition, value and status. This article highlights some of the key barriers to achieving this and makes suggestions on how they can be addressed within clinical trials units registered with the UK Clinical Research Collaboration.

摘要

具有克服运营挑战的培训和经验的专家试验经理通常是临床试验成功与否的关键。临床试验过程的开始和结束都受到相当大的重视,当结果公布时,负责撰写方案、获得资金和分析数据的人都会得到回报。然而,试验经理在认可、价值和地位方面往往被忽视。本文重点介绍了实现这一目标的一些关键障碍,并就如何在英国临床研究合作组织注册的临床试验单位解决这些问题提出了建议。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/b664/6567635/134cea96c4b9/13063_2019_3451_Fig1_HTML.jpg

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