“点击与 mortar”：试验中的数字化和消费主义机遇。
"Click and mortar" opportunities for digitization and consumerism in trials.
机构信息
Duke University, School of Medicine, Durham, NC, USA; Duke Clinical Research Institute, Duke University, Durham, NC, USA.
Duke University, School of Medicine, Durham, NC, USA; Duke Clinical Research Institute, Duke University, Durham, NC, USA.
出版信息
Contemp Clin Trials. 2023 Sep;132:107304. doi: 10.1016/j.cct.2023.107304. Epub 2023 Jul 20.
BACKGROUND
Digitization (using novel digital tools and strategies) and consumerism (taking a consumer-oriented approach) are increasingly commonplace in clinical trials, but the implications of these changes are not well described.
METHODS
We assembled a group of trial experts from academia, industry, non-profit, and government to discuss implications of this changing trial landscape and provide guidance.
RESULTS
Digitization and consumerism can increase the volume and diversity of trial participants and expedite recruitment. However, downstream bottlenecks, challenges with retention, and serious issues with equity, ethics, and security can result. A "click and mortar" approach, combining approaches from novel and traditional trials with the thoughtful use of technology, may optimally balance opportunities and challenges facing many trials.
CONCLUSION
We offer expert guidance and three "click and mortar" approaches to digital, consumer-oriented trials. More guidance and research are needed to navigate the associated opportunities and challenges.
背景
数字化（使用新型数字工具和策略）和消费主义（采用以消费者为导向的方法）在临床试验中越来越普遍，但这些变化的影响尚未得到充分描述。
方法
我们召集了一组来自学术界、工业界、非营利组织和政府的试验专家，讨论了这一不断变化的试验格局的影响，并提供了指导。
结果
数字化和消费主义可以增加试验参与者的数量和多样性，并加快招募速度。然而，随之而来的下游瓶颈、保留方面的挑战以及在公平性、道德和安全性方面的严重问题也可能会出现。一种“线上线下结合”的方法，将新型和传统试验的方法与深思熟虑的技术使用相结合，可能会最佳地平衡许多试验所面临的机遇和挑战。
结论
我们提供了专家指导和三种“线上线下结合”的数字化、面向消费者的试验方法。需要更多的指导和研究来应对相关的机遇和挑战。
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