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Clinical development focuses on how the drug will interact with the human body and encompasses four key phases of clinical trials, each serving a specific purpose in assessing the safety and effectiveness of new drugs. These phases overlap and build upon one another. Phase I involves a small group of healthy volunteers (typically 20-80 individuals) or, in cases where significant toxicity is expected, patients with the targeted disease, such as cancer or AIDS. The volunteers are tested for...
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Clinical trials are prospective experimental studies conducted on humans to determine the safety and efficacy of treatments, drugs, diet methods, and medical devices. Using statistics in clinical trials enables researchers to derive reasonable and accurate conclusions from the collected data, allowing them to make wise decisions in uncertain situations. In medical research, statistical methods are crucial for preventing errors and bias.
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Accelerating eSource scale-up in oncology clinical trials: The i~HD Task Force initiative.

Christophe Maes1, Dipak Kalra2, Tracy Acito3

  • 1Faculty of Medicine and Health Sciences, Department of Public, Ghent University, Ghent, Belgium.

Cambridge Prisms. Precision Medicine
|November 27, 2025
PubMed
Summary

The eSource Scale-Up Task Force is developing a roadmap to overcome barriers in electronic health record (EHR) to electronic data capture (EDC) data transfer for clinical research, aiming to improve efficiency and data quality in oncology trials.

Keywords:
EHR-to-EDC data integrationclinical trial digitizationeSource implementationoncology clinical trialsresearch workflow optimization

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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.