The DIA 2018 Global Annual Meeting brings together thousands of innovators from around the globe.
Use of Electronic Health Records (EHRs) as eSource in Clinical Investigations
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 : Understand how eSource, interoperability, and the learning health care system all share a fundamental common problem that prevents merging and re-use of health care data; Describe the problem of 'second order heterogenity' in clinical research and health care.
Utilizing EHR Data: How to Enable More Efficient Digital Data Gathering Practices to Benefit Patients, Sites, and Sponsors
Aman Thukral, DrSc, MBA, MPharm
AbbVie, Inc., United States
eSource, Interoperability, and the Problem of 'Second Order Heterogeneity' in Clinical Research: A Real-World Implementation
Michael A. Ibara, PharmD
Head of Digital Healthcare
Michael Ibara Consulting, United States
Structured Sourcing in EHRs
Adam L Asare, PhD
Chief Data Officer
Quantum Leap Healthcare Collaborative, United States