- September 12, 2017
University of California, San Francisco-Stanford University CERSI
Wednesday, September 13, 2017
Laura Esserman, MD, MBA
John G. Wagner Collegiate Professor
Director of Carol Franc Buck Breast Care Center
Professor of Surgery and Radiology
University of California, San Francisco School of Medicine
About the Presentation
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. In this talk, Dr. Esserman discussed the OneSource program, a standardized system to capture patient information and data electronically in a detailed digital version of a patient’s medical history that sits on top and interfaces with current electronic health record systems (EHR). A OneSource checklist is being developed 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. Dr. Esserman discussed how this model is currently being developed for the I-SPY breast cancer clinical trials and clinical programs at the two University of California participating sites. If successful, this model will be expanded to cover other therapeutic areas outside of breast cancer. A long-term goal is to have this technology be used for any electronic health record.
About the Presenter
Dr. Laura Esserman is Professor of Surgery and Radiology at the University of California, San Francisco (UCSF) and director of the UCSF Breast Care Clinic. Her work in breast cancer spans the spectrum from basic science to public policy issues, and the impact of both on the delivery of clinical care. Dr. Esserman is recognized as a thought leader in cancer screening and overdiagnosis, as well as innovative clinical trial design. She led the creation of the University of California-wide Athena Breast Health Network, a learning system designed to integrate clinical care and research as it follows 150,000 women from screening through treatment and outcomes. She is also a leader of the innovative I-SPY TRIAL model, designed to accelerate the identification and approval of effective new agents for women with high risk breast cancers.
Please contact Amal Manseur at Amal.Manseur@fda.hhs.gov.