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Principal Investigator: Emily Ricotta
Organization: NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES
Fiscal Year: 2024
Award: $194,408
Funding agency: National Institute of Allergy and Infectious Diseases
Work on this project began with the publication of an opinion piece in Nature Medicine on the need for improving nonrandomized clinical studies from an epidemiologic, ethical, and legal standpoint.
Meta-research is currently underway to evaluate early data availability, data collection methodology, critical missing elements, and study limitations published in the first year after significant outbreaks like SARS-CoV-1, H1N1, Ebola, and Zika. Data mining via a scoping review of early literature from these epidemics is in progress with the help of the NIH Library, including a summary of the duration between identification of the outbreak and publication of the first information as well as how this information was disseminated, noting changes over time.
In September 2023, the EDMU hosted a workshop at NIH to develop a consensus on best practices for collecting data using nonrandomized study designs in epidemic settings. This stakeholder engagement workshop brought together epidemiologists, data managers, clinical standards developers, ethicists, legal experts, social scientists, and data end users to understand the current data collection landscape and develop best practices for improving data collection in the future.
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