Informatics Driven Real-World Analysis of SARS-CoV-2 Serologic Response and In-Vitro Diagnostic Accuracy
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7. PROJECT SUMMARY/ABSTRACT The Centers of Excellence in Regulatory Science and Innovation (CERSI) program allows the U.S. Food and Drug Administration (FDA) to form extramural partnerships that foster robust and innovative research to develop new tools, standards, and approaches to assess the safety, efficacy, quality, and performance of FDA- regulated products, supporting regulatory decision-making and the overall mission of the FDA. Over the past two years, the Yale-Mayo Clinic CERSI has pursued a series of innovative research projects that leverage routinely-collected, real-world data sources to assess the safety, efficacy, quality, and performance of FDA- regulated products, informing regulatory decision-making as well as manufacturers, clinicians, and patients in support of patient-centered decision-making, along with providing and supporting high-quality mentorship and training in regulatory science. The Yale-Mayo Clinic CERSI will continue this work, conducting high-quality, high-impact regulatory science research in priority areas identified by the FDA to advance clinical and post- market surveillance of drugs and biologics, medical devices, and diagnostic tests, to develop and apply novel analytics to leverage routinely-collected real-world data sources for medical product evaluation, and to foster patient-centered decision-making. Over the 5-year award, the Yale-Mayo Clinic CERSI will pursue the following specific aims: Specific Aim 1. Strengthen existing extramural partnerships between FDA and the Yale-Mayo Clinic CERSI, bridging the campuses of Yale University and Mayo Clinic, and create and foster new relationships that support the FDA's regulatory mission. Specific Aim 2. Conduct high-quality, high-impact regulatory science in collaboration with FDA to develop new tools, standards, and approaches that provide timely assessments of the safety, efficacy, quality, and performance of FDA-regulated products, thereby supporting regulatory decision-making. Specific Aim 3. Provide and support high-quality mentorship and training in regulatory science at Yale University and Mayo Clinic, strengthening regulatory science at both institutions through educational efforts and scientific exchange with FDA scientists and across the CERSI network. Specific Aim 4. Foster collaboration among the Yale-Mayo Clinic CERSI, the CERSI network, FDA, industry and other key stakeholders, including pursuit of non-federal funding to better leverage FDA-related opportunities and support the CERSI program.
