Mike's Blog

There’s been quite a bit of confusion (as well as misinformation) regarding the current status and future of N3C. We’d like to offer some enlightenment.

When the National COVID Cohort Collaborative (N3C) was established in April 2020, its mission was clear: harness the power of harmonized, real-world data incarcerated within disparate electronic health records (EHRs) to combat the COVID-19 pandemic. Fast forward to today, and the N3C is not only alive and well but also expanding into broader horizons under a new identity—N3C Clinical. With over 23 million patient records represented and 33 billion rows of data, the N3C repository has become the largest longitudinal open science clinical data resource globally. It has fueled 500+ studies, 300+ publications, and nearly 5,000 citations, shaping research, clinical strategies, and policies in profound ways.

But why limit this immense clinical data resources to just a single infectious disease? Leveraging its proven infrastructure and the lessons learned from COVID-19, N3C is now evolving to tackle a broader range of clinical challenges, affirming its commitment to advancing healthcare research and fostering innovation. So, let’s explore what N3C Clinical entails, dispel common misconceptions, and outline why N3C is poised to remain an indispensable tool for translational science and become a critical component to the future of AI-driven healthcare.

For years, healthcare research in the United States has been hamstrung by fragmented and siloed data systems. Patient records are scattered across providers, states, and systems, leaving researchers with incomplete pictures of care and outcomes. N3C addressed this challenge head-on by harmonizing data across 84 unconnected healthcare organizations, enabling researchers to conduct analyses at unprecedented scale and speed.

Take COVID-19 as a use case. N3C provided the most representative data to predict risks, refine treatments, and efficiently inform the White House COVID-19 Task Force regarding decisions with a turnaround time of mere weeks.

N3C Clinical builds on this foundation by expanding into non-COVID domains, starting with cancer and renal disease in its pilot phase. These new “tenants”—secure, domain-specific research sphere—will allow researchers to explore complex clinical questions using high-quality, linked datasets in a truly scalable manner; questions that are not necessarily amenable to traditional clinical research study approaches.

Highlights include a disease-agnostic phenotype to capture comprehensive, longitudinal records for patients with research value, instead of pulling data based on a specific disease (e.g. COVID-19). The pilot tenants are further enhanced with linkages to CMS Medicare and Medicaid claims data as well as cancer and renal transplant registry data. Importantly, other NIH ICOs (NCI, NIDDK, and ODSS) as well as HHS ASPE and FDA have partnered with N3C. In addition, NIH promoted an initiative on synthetic data generation that is currently a demonstration pilot with NAIRR (National AI Research Resource). These connections dramatically expand research possibilities, and we continue to identify other high-value linkages across new tenants as well as engage with various stakeholders interested in additional tenants. N3C Clinical is scalable because data contributions are facilitated via a single Master Data Transfer Agreement (DTA), allowing contributors to share data once and apply it across multiple research tenants reducing their data transfer requirements. Governance is designed to be scalable and adaptable, providing control over data access and use, while ensuring the highest level of data security.

Regarding confusion and misperceptions concerning N3C, let’s clear the air and be unequivocal: N3C is here for the long term. Far from winding down, N3C is evolving to meet new challenges. Extensions to existing agreements will ensure COVID-related data remains accessible through 2029, while N3C Clinical expands to address other pressing health issues, particularly chronic diseases. N3C’s infrastructure is also designed for scalability and flexibility. By continuously integrating new data sources, most recently CMS claims and disease registry data, N3C Clinical offers unparalleled depth and breadth for research. Lastly, N3C Clinical is an open platform. That said, we are currently in a pilot phase and participation in those pilots is limited. The purpose of these ongoing pilots is to inform NCATS regarding operations, governance, and technical architecture as well as more accurately understand the cost of developing and maintaining future tenants for sustainability of this resource from the standpoints of infrastructure costs as well as researcher resource needs to be able to access the enclave.

To our CTSA colleagues, site investigators, and collaborators: your support is critical to N3C’s continued success. Whether you’re a data contributor, researcher, or policy advocate, N3C Clinical will offer opportunities to shape and frame the future of healthcare research. As we move into this exciting new phase, we invite you to join us in leveraging N3C Clinical resources for impactful clinical research that will contribute to the generation of truly 21st century healthcare. Let’s carpe (diem) this opportunity together.

And everything changes, but nothing is truly lost.

- Neil Gaiman, from the Sandman series, The Wake