Dr. Laura Esserman Awarded $760K FDA Grant through UCSF-Stanford Center of Excellence in Regulatory Science and Innovation (CERSI)
Laura J. Esserman, MD, MBA has been awarded a $760K FDA Grant through the UCSF-Stanford Center of Excellence in Regulatory Science and Innovation (CERSI). CERSI is a joint undertaking among the UCSF School of Pharmacy and School of Medicine, the Stanford University School of Engineering and School of Medicine and the U.S. Food and Drug Administration (FDA), the first regulatory science and innovation center on the West Coast.
The grant funds Phase 2 of the "OneSource” Project, which is designed to address regulatory challenges of information systems relating to clinical research given the advent of EHRs and EDCs:
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 prior to use of Electronic Health Records (EHRs) or Electronic Data Capture (EDCs), because data were captured on paper case report forms. However, much has changed in the past decade for regulated clinical research where EDC systems are now ubiquitous for the capture of clinical trials 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.