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评估具有分散元素的临床试验中以患者为中心和数据完整性的方法:乳香试验性试验

Methodology for Assessing Patient Centricity and Data Integrity in Clinical Trials With Decentralized Elements: A Pilot Trial on Mastic Gum.

作者信息

Park Jiyeon, Huh Ki Young, Chung Jae-Yong, Yu Kyung-Sang

机构信息

Department of Clinical Pharmacology and Therapeutics, Seoul National University College of Medicine and Hospital, Seoul, Republic of Korea.

Department of Clinical Pharmacology and Therapeutics, Seoul National University College of Medicine and Bundang Hospital, Seongnam, Republic of Korea.

出版信息

Clin Transl Sci. 2025 Sep;18(9):e70343. doi: 10.1111/cts.70343.

Abstract

Decentralized elements enhanced patient centricity by shifting trial-related activities outside traditional trial sites. On the other hand, remote data collection poses potential risks to data integrity. Although these two are critical aspects of decentralized elements, methodologies for assessing them remain limited. We proposed a method to measure patient centricity by subtracting the participant's self-rated burden for trial-related procedures with decentralized elements from their estimated burden under the traditional approach. Additionally, we introduced an analytical framework to assess data integrity by considering the accurate performance rate, the sources of errors, and their cascading consequences. The feasibility and applicability of these methodologies were explored in a pilot clinical trial on mastic gum. Patient centricity was highest in wearable device-based drug adherence monitoring (4.30) and lowest in remote consent submission (1.80). For most trial-related procedures, patient centricity tended to be higher when participant engagement increased. However, blood sample collection recorded higher patient centricity when participants visited a nearby local hospital for nurse assistance (2.55) compared to the estimated burden of using a self-kit at home (2.35). Data integrity was lowest in wearable device-based drug adherence monitoring (88.6%), and the errors were attributable to the device being left behind, insufficient proficiency, broken WiFi connection, and depleted battery. Data integrity was second lowest in self-kit-based stool specimen collection (90.0%), and the errors led to successive delays in specimen delivery and microbiome analysis. The proposed methodologies will provide a foundation for assessing and predicting the impact of decentralized elements on clinical trials. Trial Registration: ClinicalTrials.gov identifier: NCT06005805.

摘要

去中心化元素通过将与试验相关的活动转移到传统试验地点之外,增强了以患者为中心的程度。另一方面,远程数据收集对数据完整性构成潜在风险。尽管这两者是去中心化元素的关键方面,但评估它们的方法仍然有限。我们提出了一种方法,通过从参与者在传统方法下的估计负担中减去其对具有去中心化元素的试验相关程序的自评负担来衡量以患者为中心的程度。此外,我们引入了一个分析框架,通过考虑准确执行率、错误来源及其级联后果来评估数据完整性。在一项关于乳香的试点临床试验中探索了这些方法的可行性和适用性。以可穿戴设备为基础的药物依从性监测的以患者为中心程度最高(4.30),而远程同意提交的以患者为中心程度最低(1.80)。对于大多数与试验相关的程序,当参与者参与度提高时,以患者为中心的程度往往更高。然而,与在家使用自采试剂盒的估计负担(2.35)相比,当参与者前往附近当地医院寻求护士协助进行血样采集时,以患者为中心的程度更高(2.55)。以可穿戴设备为基础的药物依从性监测中的数据完整性最低(88.6%),错误归因于设备遗漏、熟练程度不足、WiFi连接中断和电池耗尽。基于自采试剂盒的粪便标本采集的数据完整性第二低(90.0%),这些错误导致标本递送和微生物组分析连续延迟。所提出的方法将为评估和预测去中心化元素对临床试验的影响提供基础。试验注册:ClinicalTrials.gov标识符:NCT06005805。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/5e29/12408364/7c7a29f6bc32/CTS-18-e70343-g004.jpg

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