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

Area of Science:

• Clinical Research Informatics
• Health Data Management
• Oncology Clinical Trials

Background:

• eSource, specifically Electronic Health Record (EHR) to Electronic Data Capture (EDC) data transfer, offers potential benefits for clinical research, including reduced site burden, enhanced data quality, and accelerated trial timelines.
• Despite its advantages, widespread adoption of eSource is hindered by technical, regulatory, and operational challenges.

Purpose of the Study:

• To outline the objectives, collaborative approach, and key outputs of the European Institute for Innovation through Health Data's (i~HD) eSource Scale-Up Task Force.
• To address the barriers limiting the implementation of eSource in clinical research.

Main Methods:

• Formation of a multi-stakeholder initiative involving leading oncology centers and pharmaceutical sponsors.
• Development of foundational resources: readiness criteria, a performance indicator framework, and an operational playbook.
• Focus on interoperability, regulatory alignment, and real-world validation.

Main Results:

• Establishment of a consensus-driven roadmap for eSource adoption.
• Creation of practical tools to guide the implementation of eSource.
• Demonstration of the Task Force's framework applicability beyond oncology to other data-intensive therapeutic areas.

Conclusions:

• The eSource Scale-Up Task Force provides a structured approach to facilitate the adoption of EHR-to-EDC data transfer in clinical research.
• The developed framework and resources aim to overcome existing barriers, promoting efficiency and data integrity.
• The initiative's outputs are designed for broad applicability across various therapeutic areas, supporting the evolution of clinical trial data management.