Defining methods to improve eSource site start-up practices

IF 1.4 Q4 MEDICINE, RESEARCH & EXPERIMENTAL

Contemporary Clinical Trials Communications Pub Date : 2024-11-14 DOI:10.1016/j.conctc.2024.101391

Amy E. Cramer , Linda S. King , Michael T. Buckley , Peter Casteleyn , Cory Ennis , Muayad Hamidi , Gonçalo M.C. Rodrigues , Denise C. Snyder , Aruna Vattikola , Eric L. Eisenstein

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引用次数: 0

Abstract

Background

eSource software that transfers patient electronic health record data into a clinical trial electronic case report form holds promise for increasing data quality while reducing data collection, monitoring and source document verification costs. Integrating eSource into multicenter clinical trial start-up procedures could facilitate the use of eSource technologies in clinical trials.

Methods

We conducted a qualitative integrative analysis to identify eSource site start-up key steps, challenges that might occur in executing those steps, and potential solutions to those challenges. We then conducted a value analysis to determine the challenges and solutions with the greatest impacts for eSource implementation teams.

Results

There were 16 workshop participants: 10 pharmaceutical sponsor, 3 academic site, and 1 eSource vendor representative. Participants identified 36 Site Start-Up Key Steps, 11 Site Start-Up Challenges, and 14 Site Start-Up Solutions for eSource-enabled studies. Participants also identified 77 potential impacts of the Challenges upon the Site Start-Up Key Steps and 70 ways in which the Solutions might impact Site Start-Up Challenges. The most important Challenges were: [1] not being able to identify a site eSource champion and [2] not agreeing on an eSource approach. The most important Solutions were: [1] eSource vendors accepting electronic data in the Health Level 7 Fast Healthcare Interoperability Resources (HL7® FHIR®) standard, [2] creating standard content for eSource-related legal documents, and [3] creating a common eSource site readiness checklist.

Conclusions

Site start-up for eSource-enabled multi-center clinical trials is a complex socio-technical problem. This study's Start-Up Solutions provide initial steps for scalable eSource implementation.

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确定改进电子资源网站启动做法的方法

背景eSource软件能将患者电子健康记录数据传输到临床试验电子病例报告表中，有望提高数据质量，同时降低数据收集、监控和源文件验证成本。将 eSource 整合到多中心临床试验启动程序中可促进 eSource 技术在临床试验中的应用。方法我们进行了定性综合分析，以确定 eSource 研究机构启动的关键步骤、执行这些步骤时可能遇到的挑战以及应对这些挑战的潜在解决方案。然后，我们进行了价值分析，以确定对 eSource 实施团队影响最大的挑战和解决方案：研讨会共有 16 位参与者：10 位制药赞助商、3 位学术机构和 1 位 eSource 供应商代表。与会者确定了启用 eSource 研究的 36 个研究机构启动关键步骤、11 个研究机构启动挑战和 14 个研究机构启动解决方案。与会者还确定了 77 个 "挑战 "对 "研究机构启动关键步骤 "的潜在影响，以及 70 种 "解决方案 "可能对 "研究机构启动挑战 "产生影响的方式。最重要的挑战是[1] 无法确定站点电子资源负责人；[2] 无法就电子资源方法达成一致。最重要的解决方案是[1] 电子源供应商接受健康等级 7 快速医疗保健互操作性资源 (HL7® FHIR®) 标准中的电子数据，[2] 为电子源相关法律文件创建标准内容，以及 [3] 创建通用的电子源研究机构准备情况检查表。本研究的 "启动解决方案 "为可扩展的 eSource 实施提供了初始步骤。

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

Contemporary Clinical Trials Communications Pharmacology, Toxicology and Pharmaceutics-Pharmacology

CiteScore

2.70

自引率

6.70%

发文量

146

审稿时长

20 weeks

期刊介绍： Contemporary Clinical Trials Communications is an international peer reviewed open access journal that publishes articles pertaining to all aspects of clinical trials, including, but not limited to, design, conduct, analysis, regulation and ethics. Manuscripts submitted should appeal to a readership drawn from a wide range of disciplines including medicine, life science, pharmaceutical science, biostatistics, epidemiology, computer science, management science, behavioral science, and bioethics. Contemporary Clinical Trials Communications is unique in that it is outside the confines of disease specifications, and it strives to increase the transparency of medical research and reduce publication bias by publishing scientifically valid original research findings irrespective of their perceived importance, significance or impact. Both randomized and non-randomized trials are within the scope of the Journal. Some common topics include trial design rationale and methods, operational methodologies and challenges, and positive and negative trial results. In addition to original research, the Journal also welcomes other types of communications including, but are not limited to, methodology reviews, perspectives and discussions. Through timely dissemination of advances in clinical trials, the goal of Contemporary Clinical Trials Communications is to serve as a platform to enhance the communication and collaboration within the global clinical trials community that ultimately advances this field of research for the benefit of patients.