Laura Esserman, MD, MBA, Adam Asare, PhD, Sue Dubman, University of California, San Francisco (UCSF)
Mitra Rocca, Dipl. Inform. Med., Gideon (Scott) Gordon, PhD, Mary Ann Slack
October 2015 - October 2019
Regulatory Science Challenge
Clinical trials for new drugs require the collection of information and data about patients enrolled in the trials. The information systems and the underlying data models and standards that define clinical care and regulated clinical research are highly variable. This lack of uniformity was not an issue for the conduct of regulated clinical research before use of Electronic Health Records (EHRs) or Electronic Data Capture systems (EDCs) because data were captured on paper case report forms.
However, much has changed in the past decade for regulated clinical research in which EDCs are now common for the capture of clinical trial data. Similarly, EHRs and other health information technology (health IT) systems have been widely adopted and are rapidly becoming a standard part of clinical care.
Project Description & Goals
The OneSource Project is a collaboration between investigators at the University of California, San Francisco (UCSF)-Stanford University Center of Excellence in Regulatory Science and Innovation (CERSI) and FDA. The goal of this project is to develop methods and tools to automate the flow of structured EHR data into external systems and thereby reduce operating costs, save time, and improve data quality for clinical trials.
We have demonstrated an approach to transmit structured data from the UCSF EHR system to a clinical trial EDC system. In this approach, we populated electronic case report forms (eCRFs) for a phase II clinical trial, (Investigation of Serial Studies to Predict Your Therapeutic Response with Imaging And moLecular Analysis 2 (I-SPY 2 TRIAL)).
OneSource leverages standards from Health Level 7 (HL7), Clinical Data Interchange Standards Consortium (CDISC), and Integrating the Healthcare Enterprise (IHE) for the capture and transmission of clinical research data. The goal of the work is to harmonize the data elements and use better tools for data capture that could make these key elements available for healthcare providers. Electronic patient reported outcomes (ePRO) was also implemented as part of OneSource for source data capture from patients in the I-SPY 2 TRIAL.
The electronic capture of data from EHRs and ePRO devices, digital imaging, and mobile health devices could improve the reliability, quality, traceability (provenance), and integrity of data from electronic source to regulatory submission. In pursuing this goal, OneSource follows recommendations in two FDA guidances:
- Electronic Source Data in Clinical Investigations” (eSource), which encourages use of electronic source data in the conduct of regulated clinical trials.
- Use of Electronic Health Record Data in Clinical investigations, which encourages use of EHRs in FDA-regulated clinical investigations and promotes the interoperability of EHR and Electronic Data Capture (EDC) systems.
This project was funded, in part, by the Patient-Centered Outcomes Research Trust Fund (PCORTF) investment opportunity through a competitive application process administered by the Office of the Assistant Secretary for Planning and Evaluation (ASPE), Department of Health and Human Services.
In this project, an end-to-end (EHR to EDC) standards-based technology solution was developed to capture and transmit clinical research data. The project team conducted a gap analysis between clinical data elements collected in a healthcare setting by EHRs vs. clinical data elements required for regulated clinical research, focusing on three key I-SPY 2 TRIAL Case Report Forms.
Source Data Capture from Electronic Health Records (EHRs): Using Standardized Clinical Research Data (OneSource) Report (PDF-2MB) describes the development process and approach to electronic source implementation at UCSF.
HHS ASPE PCORTF Project on Source Data Capture from Electronic Health Records (EHRs): Using Standardized Clinical Research Data