Remote Monitoring in Clinical Trials During the COVID-19 Pandemic

被引：39

作者：

Izmailova, Elena S. ^{[1
]}

Ellis, Robert ^{[1
]}

Benko, Christopher ^{[1
]}

机构：

[1] Koneksa Hlth, New York, NY 10038 USA

来源：

CTS-CLINICAL AND TRANSLATIONAL SCIENCE | 2020年 / 13卷 / 05期

关键词：

D O I：

10.1111/cts.12834

中图分类号：

R-3 [医学研究方法]; R3 [基础医学];

学科分类号：

1001 ;

摘要：

The coronavirus disease 2019 (COVID-19) pandemic has rapidly challenged the pharmaceutical industry to implement remote clinical trials. The industry's lack of extensive experience with remote measurements initiates multiple questions about how to select candidates for remote collection, their validity, and regulatory implications of moving certain assessments to a remote mode. We propose a decision tree for migration of clinic to remote assessments and highlight activities required to ensure that these measurements are valid, safe, and usable.

引用

页码：838 / 841

页数：4

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