CORE's Current Projects
Massive data collections derived from millions of daily interactions within the health care system are increasingly available, but we urgently need more advanced tools to support research that can produce better personalized predictions about prognosis and response to treatments; a deeper understanding of the complex factors and their interactions that influence health at the level of the patient, the health system, and society; and more effective methods of causal inference, mitigating bias and error. We also need to find new ways to think about data, while promoting its value for individuals and organizations in the service of promoting better decisions and outcomes. Accordingly, we have assembled a remarkable team of world-class experts with complementary skills who are dedicated to deep collaboration in order to produce high impact methods and tools, primed for widespread use, that will unleash the information potential of data produced as part of routine health care delivery.
Our Quality Measurement Group's ongoing work with the Centers for Medicare & Medicaid Services (CMS) includes new measure development, research on hospital quality including evaluation of trends, disparities and geographic variation and communications with stakeholders about hospital quality, and potential expansion of outcomes measures to other health care settings.
The YODA Project advocates for the responsible sharing of clinical research data. The Project is committed to open science and data transparency, and supports research attempting to produce concrete benefits to patients, the medical community, and society as a whole. Through experience and input from the public and stakeholders, the YODA Project has iteratively developed a model to make data available to researchers in a sustainable way, in which data sharing becomes a part of the clinical research enterprise of the future. The mission of the YODA Project is to not only increase access to clinical research data, but to promote its use to generate new knowledge.
The Yale/YNHH CORE Registry Data Analytic Center (RDAC) leverages our scientific expertise and infrastructure to provide comprehensive data analytic services, using an interactive and multidisciplinary approach. Our analysis of registry-based data is employed to generate generalizable research through the conduct and development of risk scores, clinical comparative effectiveness studies, epidemiological and surveillance investigations, quality measurement design and evaluation, and pharmaceutical and medical device industry research. Underscoring our experience and commitment to collaboration, since 2007 the RDAC has presided over the analysis of almost 200 projects with dozens of investigators across the country and around the world. These projects have included the analysis of data collected in both in-hospital and outpatient settings, as well as data generated from medical record abstraction and cloud-based electronic health records.
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 Yale Collaboration to Optimize Medical Evidence and Transparency (COMET) Project was formed to serve as a trusted intermediary and provide transparent recommendations on clinical research design and medical product evidence generation. As an effort by academically-based clinical researchers, the Yale COMET Project operates independently of regulators, manufacturers and payers to serve the best interests of patients and the public, while respecting concerns of other stakeholders. An independent organization creates a separation from stakeholders that builds trust in the process, strengthens its integrity, and reduces opportunities for real or perceived influence. We provide fair and impartial assessments of what is needed to advance medical therapeutic and technology evaluation.
NEST is a voluntary network of health organizations aiming to efficiently develop Real World Evidence (RWE) using Real World Data (RWD) to inform medical device evaluation and support regulatory decision-making throughout the total product life cycle. In September 2016, FDA awarded a grant for the NEST Coordinating Center (NESTcc) to the Medical Device Innovation Consortium (MDIC), a public-private partnership organization based in the Washington, DC area.