An open-source system for efficient clinical trial support: The COMET study experience.
An open-source system for efficient clinical trial support: The COMET study experience.
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DOI：
10.1371/journal.pone.0293874
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发表时间：
2023
期刊：
影响因子：
3.7
通讯作者：
中科院分区：
文献类型：
--
作者：
运动临床试验是复杂的，后勤负担，并需要一个良好的协调多学科的方法。挑战包括管理、策划和报告许多不同的信息源，同时保持对各种利益相关者的响应。联合运动试验（COMET，NCT 04848038）是对社区中提供的三种运动方式进行的为期一年的比较。目标入组人数为280人，为期4年。为了支持严格执行COMET，研究小组开发了一套脚本和仪表板，以协助研究利益相关者履行其各项职能。其结果是一个高度自动化的研究系统，保持严谨，增加沟通，并减少工作人员的负担。这份手稿描述了系统的考虑因素和COMET的数据管理和使用方法，目的是鼓励其他研究小组在各个领域的进一步发展和适应。
Exercise clinical trials are complex, logistically burdensome, and require a well-coordinated multi-disciplinary approach. Challenges include managing, curating, and reporting on many disparate information sources, while remaining responsive to a variety of stakeholders. The Combined Exercise Trial (COMET, NCT04848038) is a one-year comparison of three exercise modalities delivered in the community. Target enrollment is 280 individuals over 4 years. To support rigorous execution of COMET, the study team has developed a suite of scripts and dashboards to assist study stakeholders in each of their various functions. The result is a highly automated study system that preserves rigor, increases communication, and reduces staff burden. This manuscript describes system considerations and the COMET approach to data management and use, with a goal of encouraging further development and adaptation by other study teams in various fields.
影响因子：
2.2
作者：
Szabo-Reed, Amanda;Clutton, Jonathan;White, Sydney;Van Sciver, Angela;White, Dreu;Morris, Jill;Martin, Laura;Lepping, Rebecca;Shaw, Ashley;Puchalt, Jaime Perales;Montgomery, Robert;Mahnken, Jonathan;Washburn, Richard;Burns, Jeffrey;Vidoni, Eric D.
通讯作者：
Vidoni, Eric D.