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去中心化临床试验在癌症药物研发中的作用:肿瘤学家和患者调查结果

Role of decentralized clinical trials in cancer drug development: Results from a survey of oncologists and patients.

作者信息

de Las Heras Begoña, Daehnke Adam, Saini Kamal S, Harris Melissa, Morrison Kenneth, Aguilo Ariel, Chico Isagani, Vidal Laura, Marcus Robin

机构信息

Labcorp Drug Development Inc., Burlington, North Carolina, USA.

Madrid Medical Doctors Association, Spain.

出版信息

Digit Health. 2022 May 25;8:20552076221099997. doi: 10.1177/20552076221099997. eCollection 2022 Jan-Dec.

Abstract

As a result of the unprecedented challenges imposed by the COVID-19 pandemic on enrollment to cancer clinical trials, there has been an urgency to identify and incorporate new solutions to mitigate these difficulties. The concept of decentralized or hybrid clinical trials has rapidly gained currency, given that it aims to reduce patient burden, increase patient enrollment and retention, and preserve quality of life, while also increasing the efficiency of trial logistics. Therefore, the clinical trial environment is moving toward remote collection and assessment of data, transitioning from the classic site-centric model to one that is more patient-centric.

摘要

由于新冠疫情给癌症临床试验的入组带来了前所未有的挑战,因此迫切需要识别并采用新的解决方案来缓解这些困难。去中心化或混合型临床试验的概念迅速流行起来,因为它旨在减轻患者负担、增加患者入组和留存率、保持生活质量,同时还能提高试验后勤效率。因此,临床试验环境正在朝着远程数据收集和评估发展,从传统的以研究点为中心的模式转变为更以患者为中心的模式。

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