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. 2025 May;59(3):629-641.
doi: 10.1007/s43441-025-00748-4. Epub 2025 Mar 18.

Increasing the Utility of Real-World Data to Inform Public Health Decision Making Through a US-based Private-Public Partnership: 10 Lessons Learned from a Principled Approach to Rapid Pandemic RWE Generation

Nicolle M Gatto  1 , Elizabeth M Garry  2 , Melanie Wang  2 , Névine Zariffa  3 , Laura Roe  4 , Aloka Chakravarty #  5 , Donna Rivera #  6
Affiliations

Increasing the Utility of Real-World Data to Inform Public Health Decision Making Through a US-based Private-Public Partnership: 10 Lessons Learned from a Principled Approach to Rapid Pandemic RWE Generation

Nicolle M Gatto et al. Ther Innov Regul Sci. 2025 May.

Abstract

In response to the COVID-19 pandemic, a collaborative public-private partnership was launched to harness evidence from rapidly accruing real-world data (RWD) in various healthcare settings, with the goal of characterizing and understanding COVID-19 in near real-time, by applying rigorous epidemiological methods and defining research best practices. Projects were conducted in 4 phases: Research Planning and Prioritization, Protocol Development, Protocol Implementation, and Results Dissemination. During these projects, areas were identified with a current or future need to enhance existing best practices. This report provides a summary of our research processes, including application of new and existing practices, along with key learnings related to the challenges of conducting research when the clinical landscape is rapidly evolving as was the case during the first year of the COVID-19 pandemic. Such processes and learnings may be helpful to the broader research community when using RWD to understand or address future public health priorities.

Keywords: COVID-19; Epidemiologic methods; Pandemic preparedness; Real-world data; Real-world evidence; SARS-CoV-2.

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Conflict of interest statement

Declarations. Conflict of interest: This paper reflects the views of the authors and should not be construed to represent FDA views or policies. Dr. Gatto, Dr. Garry and Ms. Wang are employees of Aetion, Inc., with stock options. During the design, analysis, and interpretation of the research project, Ms. Roe and Ms. Zariffa were affiliated with the U.S. Food and Drug Administration. All other authors declared no competing interests for this work.

Figures

Figure 1
Figure 1
Proposed process for descriptive and comparative effectiveness studies with designated checkpoints required to proceed.
See this image and copyright information in PMC

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