加速肿瘤临床试验的资源扩大:i~HD工作组倡议。

Cambridge prisms, Precision medicine Pub Date : 2025-10-14 eCollection Date: 2025-01-01 DOI:10.1017/pcm.2025.10004
Christophe Maes, Dipak Kalra, Tracy Acito, Nadir Ammour, Paul Basset, Sarah Burge, Peter Castleyn, Ross Caldow, Camille Couvert, Amy Cramer, Chris Harrison, Joeri Holtzem, Pavitra Mariappan, Paul Jacobs, Lars Fransson, Veronique Berthou, Laurice Jackson, Nancy Wetzel, Christopher Thompson, Sharon Klein, Robert Green, Fakhry Kaoukdji, Michael Ward, Felix Nensa, Joe Lengfellner, Anna Patruno, Dawn Snow, Isabel Virchow, Angela Fritsche, Pascal Coorevits, Mats Sundgren
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引用次数: 0

摘要

eSource(特别是EHR-to-EDC)是临床研究中的一种新兴范例,它能够将电子健康记录(EHR)数据自动转移到电子数据采集(EDC)系统中,具有减轻现场负担、提高数据质量和加快肿瘤临床试验工作流程的潜力。然而,由于技术、管理和操作方面的障碍,广泛实施仍然有限。为了应对这些挑战,欧洲卫生数据创新研究所(i~HD)于2024年启动了资源扩大工作组。这一多方利益相关者倡议汇集了领先的肿瘤中心和制药赞助商,为eSource的采用建立共识驱动的路线图。这项工作的核心是三个基础资源:早期采用者的准备标准,监测成功的绩效指标框架和指导实施的操作手册。本文提供了Task Force的目标、协作模型和输出的结构化概述,并特别关注其对互操作性、法规一致性和实际验证的关注。虽然最初是为肿瘤学开发的,但工作组的框架适用于以数据密集型工作流程为特征的治疗领域。
本文章由计算机程序翻译,如有差异,请以英文原文为准。

Accelerating eSource scale-up in oncology clinical trials: The i~HD Task Force initiative.

Accelerating eSource scale-up in oncology clinical trials: The i~HD Task Force initiative.

Accelerating eSource scale-up in oncology clinical trials: The i~HD Task Force initiative.

Accelerating eSource scale-up in oncology clinical trials: The i~HD Task Force initiative.

eSource - particularly EHR-to-EDC - is an emerging paradigm in clinical research that enables automated transfer of electronic health record (EHR) data into electronic data capture (EDC) systems, with the potential to reduce site burden, improve data quality and accelerate oncology clinical trial workflows. However, widespread implementation remains limited due to technical, regulatory and operational barriers. To address these challenges, the European Institute for Innovation through Health Data (i~HD) launched the eSource Scale-Up Task Force in 2024. This multi-stakeholder initiative brings together leading oncology centres and pharmaceutical sponsors to establish a consensus-driven roadmap for eSource adoption. Central to this effort are three foundational resources: readiness criteria for early adopters, a performance indicator framework for monitoring success and an operational playbook to guide implementation. This article provides a structured overview of the Task Force's objectives, collaborative model and outputs, with specific attention to its focus on interoperability, regulatory alignment and real-world validation. While initially developed for oncology, the Task Force's framework is applicable across therapeutic areas characterized by data-intensive workflows.

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