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Use of Electronic Health Records (EHRs) as eSource in Clinical Investigations
Session Chair(s)
Mitra Rocca, MSc
Associate Director, Medical Informatics, Office of Translational Science, CDER
FDA, United States
Electronic health records (EHRs) are a valuable tool for clinical research and can serve as the source of information in clinical trials. EHR data can be used for protocol design and feasibility, patient recruitment, identification of sites and investigators, monitoring adverse drug events, patient outcomes improvement and other aspects of clinical research. However, EHRs are designed to meet healthcare needs.In order to use EHRs for clinical research, there is a need to develop guidances, enhance existing data standards and conduct projects. This session will focus on the ongoing projects led by various stakeholders (FDA, biopharmaceuticals, electronic health records and electronic data capture vendors, academic medical centers, and standards development organization). This session will discuss the current state of the guidance developed by FDA focusing on the "Use of Electronic Health Record Data in Clinical Investigations".
Learning Objective : Describe the ongoing efforts at FDA, industry, and academia leveraging electronic health records (EHRs) in clinical investigations.
Speaker(s)
Utilizing EHR Data: How to Enable More Efficient Digital Data Gathering Practices to Benefit Patients, Sites, and Sponsors
Aman Thukral, MPharm, MS
AbbVie, Inc., United States
Head of Digital Operations & Clinical Systems Data and Statistical Science (DSS)
eSource, Interoperability, and the Problem of 'Second Order Heterogeneity' in Clinical Research: A Real-World Implementation
Michael A. Ibara, PharmD
Elligo Health Research, United States
Chief Data Officer
Structured Sourcing of EHR Data for Process and Quality Improvements in the I-SPY 2 Trial
Adam L Asare, PhD
Quantum Leap Healthcare Collaborative, United States
Chief Data Officer
Panelist
Jean-Francois Ethier
Universite de Sherbrooke, Canada
Prof. Agrege, Service de medicine interne
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