Creating a Clinical Evidence Data Platform for COVID-19

Dear CTSA PIs,

We are facing an unprecedented time with the COVID-19 pandemic. I have heard from many of you how difficult and challenging this has been to your lives, your research, and your care of patients.  At the same time, I have been enormously impressed and gratified by the work you are all doing to lead COVID-19-related efforts at your institutions, region, and the nation, and your desire to work together to share and augment your individual efforts to produce a whole that is greater than the sum of the parts.  I have spoken to many of you about your desire for NCATS and the CTSA program to provide leadership on clinical translational efforts nationally.  I want you to know that I strongly agree.  The opportunity and obligation we had when the opioid crisis began is the same here, only in a much more urgent way.

In trying to address this global emergency to support the development, testing and dissemination of promising treatments, many questions have arisen with no straightforward answers. We lack reliable information and data to address issues such as: who is infectious, who may need hospital care and at what level, what are the key risk factors, what are the best prognostic indicators, what are the best practices for ethical resource allocation, and which drugs are the most viable candidates for patients.

We believe that a centralized, open-access data portal, with oversight through a scientific committee, of a limited data set of COVID-19 clinical data would be a critical resource to help address these questions. Organizations across the US Department of Health and Human Services including NIH are in discussions for creating this Clinical Evidence Data Platform for COVID-19 (a final name has not yet been finalized). We are also working with distributed clinical data networks like PCORnet, OHDSI, ACT/i2b2, and TriNetX, just to name a few.

The goal is to synergize our collective efforts to address the pandemic by creating a centralized, secure, cloud-based collaboration portal. To minimize the effort required by network partners, NCATS will accept data from multiple data models and transform them into a common analytic model.

This resource will provide access to a large row-level limited dataset required for machine learning and other informatics tools to be developed. An overarching objective is that this platform and its resources will support the high-quality collection of data needed to accelerate and streamline clinical trials on promising findings to address the pandemic. FDA will provide technical assistance to inform research objectives, study design, and priorities.

NCATS will have a leadership role in this NIH effort and plans to utilize the National Center for Data to Health (CD2H) and their cloud infrastructure. As you all know and have participated in, NCATS has done much work in the last several years, both within the CTSA program and in other programs, that can enable rapid maturation and deployment of national clinical informatics capacity such as this. While more information on this new initiative will be forthcoming and discussed on upcoming calls, I am contacting you now to request your assistance in making your informatics leadership aware of this important development.

We are still determining if funds will be made available to assist in this effort. NCATS will schedule a call as soon as our plans with the rest of NIH are finalized.

The scenario we currently face is when our innovative and collaborative expertise and resources, and our national network of clinical and translational science experts, are most urgently needed. Together, we can help slow and ultimately end this pandemic.

As always, I am grateful for your partnership.

With best wishes, and stay safe,

Christopher P. Austin, MD
Director