eSource for Scaling Up Clinical Trials Programme

About

Currently, up to 70% of clinical trial data is duplicated between research systems and hospital Electronic Health Records (EHRs), accounting for about 20% of study costs.* With HL7 FHIR standards and SMART on FHIR APIs, large-scale electronic patient data transfer to study databases is now feasible.

EHR to EDC (Electronic Health Record to Electronic Data Capture) or EHR as eSource, streamlines the transfer of EHR data for clinical research. Conducted with patient consent and quality checks, this process meets regulatory eSource requirements, integrating data into an EDC system or the sponsor’s study database without replacing site staff or duplicating data capture.

Automated data transfer minimises site burden, accelerates trial timelines, improves data quality, and enhances patient safety. Additionally, it significantly reduces the need for Source Data Verification (SDV), contributing to overall cost savings. Integrating EHR and EDC systems strengthens relationships with investigational sites, optimises protocols, and enhances clinical trial efficiency.

*Kalankesh L.R, et al. (2024) Utilization of EHRs for clinical trials: a systematic review. BMC Medical Research Methodology BMC Medical Research Methodology Vol 24:70.

Mission

The mission of the “eSource EHR Programme” is to collectively drive and scale eSource implementation, revolutionising the setup and execution of clinical trials worldwide.

Emphasising a unified approach

The collaborative model draws from the legacy of pioneering projects like EHR4CR, EHR2EDC and EU-PEARL to advance recommendations and experiences impartially across vendors, pharmaceutical companies and hospitals.

The collaboration focuses on

  • Establishing early adopters’ minimum criteria for success, including hospitals, EHR2EDC, EHR and EDC vendors.
  • Developing a Cross-Pharma EHR2EDC playbook for eSource-enabled trial setup and execution.
  • Influencing interoperability standards, EHR solution providers and hospitals to prioritise common research data elements.

Task Force

The European Institute for Innovation through Health Data (i~HD) has launched the eSource Scale Up Task Force, aimed at transforming clinical trial data collection. The task force features i~HD invitation-only members from industry and healthcare organisations. 

What the Task Force will do

  • Drive and scale the adoption of Electronic Health Record (EHR) as eSource technology across pharma/biotech companies and hospitals
  • Promote alignment across members to adopt harmonised and efficient practices and processes
  • Engage with relevant organisations and stakeholders involved in eSource EHR initiatives

Outputs

  • Position papers
  • Scientific publications
  • Recommendations
  • Webinars
  • Playbooks
  • Conference participation

How the Task Force will perform

Collaboration using the “Chatham House rules” under i~HD membership banner.

2024-2025 Scope

Site readiness

  • Enabling a network of champion sites for EHR as eSource
  • Readiness checklist
  • Awareness/education webinars to sites


Industry Playbook

  • Establish a playbook for deploying EHR direct data transfer to Sponsor
  • Define common data elements catalogue
  • Define early adopters’ minimum criteria for success for EHR to Sponsor solutions


Regulatory

  • Clarifying regulatory guidance interpretations
  • Exploring acceptable approaches and validation rules to collect regulatory-grade unstructured data using eSource technology
i~HD