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COVID-19 疫情期间通过实施远程医疗对肿瘤临床试验数据报告的影响。

Impact of COVID-19 Outbreak through Telemedicine Implementation on Data Reporting During Oncology Clinical Trials.

机构信息

Clinical Research Department, Lucien Neuwirth Cancer Institute, Saint Priest en Jarez, France.

Medical Oncology Department, Lucien Neuwirth Cancer Institute, Saint Priest en Jarez, France.

出版信息

Cancer Invest. 2021 Jan;39(1):15-20. doi: 10.1080/07357907.2020.1858311. Epub 2020 Dec 10.

Abstract

Coronavirus disease outbreak has affected all aspect of clinical care including cancer clinical trials. To minimize exposure of frail cancer patients, an implementation of telemedicine was retained. The impact of this implementation on primary and secondary endpoints criteria of ongoing clinical trials was analyzed. Out of 128 oncology clinical trials, 25 (19%) had an implementation of teleconsultation. Poor data reporting induced mainly a bias on qualitative and descriptive primary endpoints than those assessing efficacy (80% 20%;  < 0.001). The integration of telemedicine and E-technologies in the medical practices and clinical trials must be designed and validated.

摘要

冠状病毒疾病的爆发已经影响到临床护理的各个方面,包括癌症临床试验。为了尽量减少体弱癌症患者的暴露风险,保留了远程医疗的实施。分析了这一实施对正在进行的临床试验的主要和次要终点标准的影响。在 128 项肿瘤学临床试验中,有 25 项(19%)实施了远程会诊。不良的数据报告主要导致定性和描述性主要终点出现偏倚,而不是那些评估疗效的终点(80%对 20%; < 0.001)。远程医疗和电子技术必须在医疗实践和临床试验中进行设计和验证。

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