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使用电子病历集成试验匹配系统进行癌症临床试验患者筛选的开发与实施。

Development and implementation of cancer clinical trial patient screening using an electronic medical record-integrated trial matching system.

作者信息

Bui Nam, Nika Agnes, Montoya Mateo, Lopez Andrea, Newman Jasmine, Vaddadi Mounica, Guli Rahul, Rodin Melissa, Robinson Ashley, Rosenthal Eben, Artandi Steven E, Ather Sameer, Pang Yi, Neal Joel

机构信息

Stanford Cancer Institute, Stanford, California, USA

Stanford Cancer Institute, Stanford, California, USA.

出版信息

BMJ Health Care Inform. 2025 Jul 16;32(1):e101295. doi: 10.1136/bmjhci-2024-101295.

DOI:10.1136/bmjhci-2024-101295
PMID:40670040
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC12273118/
Abstract

OBJECTIVES

Clinical trial enrolment is critical for the development and approval of novel cancer therapeutics, but patient identification and recruitment to clinical trials remains low and multiple trials accrue slowly or fail to meet accrual goals. Informatics solutions may facilitate clinical trial screening, ideally improving patient engagement and enrolment. Our objective is to develop and implement a system to efficiently screen queried patients for available clinical trials.

METHODS

At Stanford, we designed and implemented a personalised clinical trial matching system, integrating our electronic medical record, clinical trials management system and a third-party software-based solution to directly connect providers with clinical research coordinators and appropriate trials.

RESULTS

Over 3 years of a staged rollout, significant increases in clinical trial screening requests and subsequent enrolment have been observed. The total number of screening referrals increased from 20 in the first year to 236 in the third year. Enrolment related to screening referrals, the 'conversion rate', ranged from 16% to 26% of referred patients.

CONCLUSION

Clinical trial matching systems can increase awareness of available trials and provide a mechanism to increase clinical trial accrual, especially when implemented at the point of care for easy access at treatment decision points. Here, we describe the process of creating and implementing a bespoke clinical trial matching software integrated into the electronic medical record. Having validated the utility of the platform, we will focus on further efforts to drive utilisation through software features.

摘要

目的

临床试验入组对于新型癌症治疗方法的研发和获批至关重要,但患者识别和招募到临床试验的比例仍然较低,多项试验进展缓慢或未能达到招募目标。信息学解决方案可能有助于临床试验筛选,理想情况下可提高患者参与度和入组率。我们的目标是开发并实施一个系统,以有效地为有需求的患者筛选可用的临床试验。

方法

在斯坦福大学,我们设计并实施了一个个性化的临床试验匹配系统,整合了我们的电子病历、临床试验管理系统以及一个基于第三方软件的解决方案,以便直接将医疗服务提供者与临床研究协调员及合适的试验联系起来。

结果

在分阶段推出的3年时间里,观察到临床试验筛选请求及后续入组率显著增加。筛选转诊的总数从第一年的20例增加到第三年的236例。与筛选转诊相关的入组率,即“转化率”,在转诊患者的16%至26%之间。

结论

临床试验匹配系统可以提高对可用试验的认知度,并提供一种提高临床试验入组率的机制,尤其是在医疗服务点实施时,以便在治疗决策点易于获取。在此,我们描述了创建并实施一个集成到电子病历中的定制临床试验匹配软件的过程。在验证了该平台的实用性之后,我们将专注于通过软件功能进一步推动其应用。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/8421/12273118/e3ab50b4789f/bmjhci-32-1-g004.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/8421/12273118/41b850afe405/bmjhci-32-1-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/8421/12273118/85dd5d46c23c/bmjhci-32-1-g002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/8421/12273118/6e2f4b18ee03/bmjhci-32-1-g003.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/8421/12273118/e3ab50b4789f/bmjhci-32-1-g004.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/8421/12273118/41b850afe405/bmjhci-32-1-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/8421/12273118/85dd5d46c23c/bmjhci-32-1-g002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/8421/12273118/6e2f4b18ee03/bmjhci-32-1-g003.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/8421/12273118/e3ab50b4789f/bmjhci-32-1-g004.jpg

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本文引用的文献

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Nat Commun. 2024 Nov 18;15(1):9074. doi: 10.1038/s41467-024-53081-z.
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Utilization of EHRs for clinical trials: a systematic review.利用电子健康记录进行临床试验:系统评价。
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Automated Matching of Patients to Clinical Trials: A Patient-Centric Natural Language Processing Approach for Pediatric Leukemia.患者与临床试验的自动匹配:一种面向儿科白血病患者的自然语言处理方法。
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Equitable Access to Clinical Trials: How Do We Achieve It?公平获得临床试验的机会:我们如何实现?
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Piloting an automated clinical trial eligibility surveillance and provider alert system based on artificial intelligence and standard data models.基于人工智能和标准数据模型,试点自动化临床试验资格监测和提供方提醒系统。
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