CERSI Collaborators: Laura Esserman, MD, MBA, University of California at San Francisco (UCSF)
FDA Collaborators: Mary Ann Slack, Ronald Fitzmartin, PhD, MBA, Mitra Rocca, PhD, Fatima Frye
Project Duration: April 2014 - September 2017
Regulatory Science Challenge
Clinical trials for new drugs require the collection of information and data about patients enrolled in the trials. Currently, there is no standard electronic system that enables accurate collection of data and promotes data-sharing across multiple clinical trial sites.
The electronic source (eSource)/One Source program is a standardized system to capture patient information and data electronically in a detailed digital version of a patient’s medical history called an electronic health record (EHR). After verification, various users, such as investigators conducting clinical trials, can share and access the data. The use of eSource for clinical trials will make it possible to exchange and incorporate information from other databases, thus speeding up clinical trials and the approval process of new drugs.
Project Description & Goals
CERSI scientists at UCSF/Stanford University are collaborating with FDA on developing an eSource checklist, the integration of standards-based tools that will enable health care professionals to track key patient information at the point of care in their EHRs and integrate clinical research and health care. This project’s goal is to leverage health care standards to enable health care professionals to keep track of the key information that drives the care of their patients.
This model is being implemented in the I-SPY2 and 3 breast cancer clinical trials by demonstrating the exchange of verified and re-usable information between clinical care and research settings. If successful, this model will be expanded to cover other therapeutic areas outside of breast cancer. A clinician checklist and an eSource widget tool are being developed and successfully integrated into the EHR system. As a long-term goal, this technology is intended to be used for any electronic health record.