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 Collaboration for Research Integrity and Transparency (CRIT) is an inter-disciplinary initiative launched in 2016 to enhance the quality and transparency of the research base for medical products. Through research, advocacy, and litigation, CRIT is focused on ensuring that the clinical evidence that supports and informs our understanding of the safety and effectiveness of pharmaceuticals, medical devices, and other medical products is accurate, comprehensive, accessible, and reliable. The lack of transparency and integrity in clinical research has had serious consequences for patient and clinicians.
The surveillance of medical devices is intended to provide critical information to all relevant stakeholders about device safety, long-term product performance, and effectiveness in improving patient outcomes. However, we are far from this ideal system. Yale University, in partnership with Medtronic, Inc., has been selected to receive a five-year cooperative agreement from the U.S. Food and Drug Administration (FDA) that will develop methods and facilitate best practices for medical device surveillance.
The objective of the Global Health initiative is to strengthen the health care systems for cardiovascular disease around the world, with a current focus on China.
Since 2007, Yale CORE has served as a data analytic center (DAC) for the ICD RegistryTM and the CathPCI Registry® of the American College of Cardiology Foundation’s National Cardiovascular Data Registry (NCDR®). More recently, NCDR's ACTION Registry®, LAAO RegistryTM and Afib Ablation RegistryTM were added to the stable of Yale CORE NCDR registries. The goal of this work is to generate new knowledge and insights into the care of patients with cardiovascular disease through analysis of the robust data submitted to the NCDR® registries. A team of CORE researchers work closely with NCDR® staff to provide logistical and analytical support for research proposals related to its ICD Registry®, CathPCI RegistryTM, ACTION Registry®, LAAO RegistryTM and Afib Ablation RegistryTM.
The Yale University-Mayo Clinic Center of Excellence in Regulatory Science and Innovation (CERSI) is a recently established 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.