The study and improvement of data collection and management for infectious diseases and immunodeficiencies

National Institute Of Allergy And Infectious Diseases

Investigators

Linked publications, trials & patents

Abstract

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 is hosting 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 will bring 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. The workshop will consist of participatory discussions prompted by original writings/talks by participants, carefully selected background readings, and a series of pre-identified questions. Output will include a formal report as well as a peer-reviewed manuscript with consensus recommendations for improving non-randomized studies in epidemic settings.