Good Science in Compliance: Optimizing Remote Clinical Trial Management: A Multi-Site Analysis of Virtual Monitoring Implementation

IF 2.3 4区医学 Q1 MEDICINE, GENERAL & INTERNAL

Journal of the National Medical Association Pub Date : 2025-09-01 DOI:10.1016/j.jnma.2025.08.011

Mary C. Blake MS, DrPH (in progress)

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引用次数: 0

Abstract

Introduction

The COVID-19 pandemic accelerated the adoption of remote clinical trial monitoring, yet standardized protocols for virtual oversight remain inconsistent across research sites. This study evaluates the effectiveness of a hybrid monitoring approach implemented across multiple research centers, focusing on data quality, protocol adherence, and resource utilization.

Methods

A retrospective analysis was conducted across 12 research sites from 2021-2024, examining clinical trials that utilized both traditional on-site and remote monitoring approaches. Data was collected from three primary sources: electronic data capture systems, monitoring visit reports, and site performance metrics. Key performance indicators included protocol deviation rates, query resolution time, and data entry completion rates. Statistical analysis was performed using SPSS and Python, with significance set at p<0.05.

Results

Remote monitoring implementation resulted in a 32% reduction in monitoring-related costs while maintaining data quality standards. Sites utilizing the hybrid approach demonstrated comparable protocol adherence rates to traditional monitoring (98.2% vs. 97.8%, p=0.67). Query resolution time improved by 45% (mean 3.2 days vs. 5.8 days, p<0.001) with the implementation of virtual monitoring tools. Site staff reported increased satisfaction with flexible monitoring schedules (satisfaction score 4.2/5 vs. 3.6/5, p<0.01).

However, technology infrastructure limitations at 25% of sites necessitated additional support and training.

Conclusion

The implementation of remote monitoring strategies demonstrates significant potential for improving clinical trial efficiency while maintaining quality standards. These findings suggest that a hybrid monitoring approach can effectively support clinical trial oversight while reducing operational costs and improving staff satisfaction. Future research should focus on standardizing remote monitoring protocols and addressing technology infrastructure challenges across diverse research settings.

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良好的依从性科学：优化远程临床试验管理：虚拟监测实施的多站点分析

2019冠状病毒病大流行加速了远程临床试验监测的采用，但各研究点的虚拟监督标准化方案仍不一致。本研究评估了跨多个研究中心实施的混合监测方法的有效性，重点关注数据质量、协议遵守和资源利用。方法回顾性分析2021-2024年12个研究点的临床试验，包括采用传统现场监测和远程监测方法的临床试验。数据收集有三个主要来源：电子数据采集系统、监测访问报告和站点性能指标。关键性能指标包括协议偏差率、查询解析时间和数据输入完成率。采用SPSS和Python进行统计学分析，显著性设为p<；0.05。结果在保持数据质量标准的同时，远程监测的实施使监测相关成本降低了32%。使用混合方法的站点显示出与传统监测相当的协议依从率（98.2%对97.8%,p=0.67）。通过实现虚拟监控工具，查询解析时间提高了45%（平均3.2天vs. 5.8天，p<0.001）。现场工作人员报告对灵活监控时间表的满意度增加（满意度评分4.2/5比3.6/5,p<0.01）。然而，在25%的站点，技术基础设施的限制需要额外的支持和培训。结论实施远程监护策略在保持临床试验质量标准的同时，具有提高临床试验效率的潜力。这些发现表明，混合监测方法可以有效地支持临床试验监督，同时降低运营成本并提高员工满意度。未来的研究应侧重于标准化远程监测协议，并解决不同研究环境下的技术基础设施挑战。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Journal of the National Medical Association 医学-医学：内科

CiteScore

4.80

自引率

3.00%

发文量

139

审稿时长

98 days

期刊介绍： Journal of the National Medical Association, the official journal of the National Medical Association, is a peer-reviewed publication whose purpose is to address medical care disparities of persons of African descent. The Journal of the National Medical Association is focused on specialized clinical research activities related to the health problems of African Americans and other minority groups. Special emphasis is placed on the application of medical science to improve the healthcare of underserved populations both in the United States and abroad. The Journal has the following objectives: (1) to expand the base of original peer-reviewed literature and the quality of that research on the topic of minority health; (2) to provide greater dissemination of this research; (3) to offer appropriate and timely recognition of the significant contributions of physicians who serve these populations; and (4) to promote engagement by member and non-member physicians in the overall goals and objectives of the National Medical Association.