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技术临床试验:将创新转化为患者受益。

Technology clinical trials: Turning innovation into patient benefit.

作者信息

Royle Jennifer K, Hughes Andrew, Stephenson Laura, Landers Dónal

机构信息

digital Experimental Cancer Medicine Team, Cancer Research UK Manchester Institute, University of Manchester, Manchester, UK.

Division of Cancer Sciences, University of Manchester, Manchester, UK.

出版信息

Digit Health. 2021 Apr 30;7:20552076211012131. doi: 10.1177/20552076211012131. eCollection 2021 Jan-Dec.

Abstract

Health care needs to continuously evolve and innovate to maintain the health of populations. Technology has the potential to enable better patient engagement and ownership, as well as optimise therapeutic interventions and data-science approaches to facilitate improved health care decisions. Yet, to date, technological innovation has not resulted in the rate of change that could have been predicted from other sectors. This article discusses multiple reasons for this and proposes a newly tested and deployed solution: the technology clinical trial. The technology clinical trial methodology has been developed through working directly with patients, clinical and medical devicetrial experts. This approach enables researchers to use the complex environment of health care as an opportunity to transform the pace of innovation and create new care pathways. Instead of testing a single innovation, researchers can 'step back' and systematically review all areas of the patient's journey for potential optimization. Then integrate novel data science, technological advances, process updates, behavioural science, and patient engagement to co-create a streamlined multidisciplinary solution. As a result, this research has the potential for larger advances due to the emergent benefits that can arise when the individual elements work together as a whole. These potential benefits are then robustly tested, characterised and measured in the trial environment to ensure that future application of the innovative pathway is supported by the robust empirical data health care requires.

摘要

医疗保健需要不断发展和创新,以维护民众的健康。技术有潜力促进更好的患者参与和自主管理,优化治疗干预措施以及数据科学方法,以推动做出更优的医疗保健决策。然而,迄今为止,技术创新并未带来如其他行业所预期的变革速度。本文探讨了造成这种情况的多个原因,并提出了一种新测试和部署的解决方案:技术临床试验。技术临床试验方法是通过直接与患者、临床和医疗设备试验专家合作而开发的。这种方法使研究人员能够利用医疗保健的复杂环境,将其作为加快创新步伐和创造新护理途径的契机。研究人员不是测试单一创新,而是可以“退后一步”,系统地审视患者就医过程的所有领域,以寻求潜在的优化。然后整合新颖的数据科学、技术进步、流程更新、行为科学和患者参与,共同创造一个精简的多学科解决方案。因此,由于各个要素作为一个整体协同工作时可能产生的新兴效益,这项研究有可能取得更大的进展。然后,在试验环境中对这些潜在效益进行严格测试、特征描述和衡量,以确保创新途径的未来应用得到医疗保健所需的可靠实证数据的支持。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/d4f1/8114771/8b4e84109d63/10.1177_20552076211012131-fig1.jpg

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