Yale University-Mayo Clinic CERSI
The Yale University-Mayo Clinic Center of Excellence in Regulatory Science and Innovation (CERSI) is a joint effort between Yale University, Mayo Clinic, and the U.S. Food and Drug Administration (FDA) to create infrastructure for regulatory science knowledge generation, conduct research to address key gaps in knowledge, and develop tools to support regulatory decision-making and the overall mission of FDA. The FDA Office of Regulatory Science and Innovation supports CERSIs at Yale-Mayo and the following sites:
- Johns Hopkins University
- University of California at San Francisco in a joint effort with Stanford University
- University of Maryland
The FDA is tasked with the complex regulatory mission of protecting public health by assuring safety, efficacy, and security of human and veterinary drugs, biological products, medical devices, food, and products that emit radiation. In addition, the FDA is responsible for regulating the manufacturing, marketing and distribution of tobacco products, for advancing public health by helping to speed innovations that make medicines more effective, safe, and affordable, and for helping the public get the accurate, science-based information they need to use medicines and foods to maintain and improve health.
The Yale-Mayo CERSI aims to create an infrastructure to support and enhance several areas of focus in the FDA strategic plan for regulatory science, including to stimulate innovation in clinical evaluations and personalized medicine to improve product development and patient outcomes, harness diverse data through information sciences to improve health outcomes, and strengthen social and behavioral science to help consumers and professionals make informed decisions about regulated products. The Yale-Mayo CERSI will use routinely-collected, real-world data sources, other existing clinical trial data, and genomic and biobank data in order to inform regulatory decision-making, build FDA capacity and capability to deploy advanced analytic methods, and disseminate the knowledge generated to ensure patient-centered regulatory decision-making, better-informed regulators, manufacturers, clinicians and patients, and support shared decision-making.
Recent News and Updates
We are pleased to announce new CERSI-supported publications! One study evaluated the need to characterize the longitudinal measurement characteristics of physical function assessments, including clinician-reported physical function (ClinRo), patient-reported physical function (PRO), performance outcome tests (PerfO) and wearable data, to inform regulatory and clinical decision-making in cancer clinical trials and oncology practice and was published as a preprint on medRxiv.
A second study that analyzed lifelong oral anticoagulation which is recommended in patients with atrial fibrillation (AF) to prevent stroke, was published in the American Heart Journal.