USCF, FDA Deploy EHR Integration for Clinical Research Trials

UC San Francisco (UCSF), in collaboration with the Quantum Leap Healthcare Collaborative (QLHC) and the Food and Drug Administration (FDA), has deployed an EHR integration that aims to streamline health data for clinical research trials.

OneSource is an electronic data capture (EDC) system based on open-source data EHR integration standards. The EHR integration allows the clinician or patient to enter clinical data at the point of care only once.

The healthcare organization can then use that single entry for trials, quality improvement, and research. The system also automates the transfer of labs, demographic information, and concurrent medications to clinical trial and registry data systems.

“Getting the OneSource system implemented is an important step forward,” Heidi Collins, vice president of clinical systems at UCSF, said in a press release. “Tools that can seamlessly work across any electronic medical record system will make it possible for data to effortlessly flow to trials and registries and serve quality improvement efforts across the medical center.”

UCSF initially conceived the framework with support from the FDA. QLHC further developed the software for production implementation at eight QLHC-sponsored I-SPY COVID TRIAL sites. OneSource enabled a 30 to 50 percent improved turnaround time for data completion associated with the trial endpoint at those sites.

By mid-2022, the organizations hope to have the EHR integration operational across 35 sites participating in I-SPY 2.2 (for breast cancer) and I-SPY COVID trials. 

“We have long needed to focus on the capture of mission-critical data at the point of care,” said Laura Esserman, MD, founder and co-principal investigator of the I-SPY Trials and director of the UCSF Breast Care Center. “OneSource enables us to learn from every patient we see, fueling the cycle of knowledge and innovation.”

“We need these same tools to match patients to resources (including clinical trials) that will improve their care experience and their outcomes,” continued Esserman. “OneSource is a building block for 21st century personalized trials that provide clinicians with data and confidence to adopt new standards of care.”

QLHC, a 501C (3) charitable organization established as a collaboration between clinical researchers at UCSF and Silicon Valley entrepreneurs, partnered with the FDA, the Center of Excellence in Regulatory Science and Innovation, and UCSF Information Technology leadership on the initiative.

“OneSource is straightforward to implement, requiring less than ten hours of configuration time using well established, secure EHR integration standards,” said Adam Asare, PhD, QLHC chief data officer and director of IT for the UCSF Breast Center. “Upon implementation, research teams are thrilled with the amount of time saved in what was previously double entry of the same data in separate systems.”

Officials said that the organizations plan to expand OneSource for use in routine clinical practice soon, allowing improved access to patient data across various clinical stakeholders.