HealthVerity has signed a multi-year Research Collaboration Agreement with the U.S. Food and Drug Administration (FDA) to evaluate a range of different real-world datasets for their potential to inform the FDA's response to COVID-19.
"The urgency of COVID-19 has elevated the need for immediate strategic industry partnerships," said Amy Abernethy, M.D., Ph.D., FDA principal deputy commissioner. "The more detail we can obtain around how COVID-19 affects different patient populations, the faster a potential treatment for coronavirus can become a reality. Developing the expertise needed to apply diverse, real-world datasets to these issues is an essential step in this direction."
In response to the COVID-19 public health emergency, the research collaboration will leverage HealthVerity's knowledge in real-world data to facilitate the evaluation of novel data sources for their potential application to support FDA's mission. As a partner, HealthVerity will help to characterize the integrity, quality and reproducibility of these sources for the purpose of generating real-world evidence to address the ongoing crisis.
The research will aim to identify and evaluate real-world data sources that will be relevant for summarizing treatment patterns among patients in the inpatient and outpatient care settings, understanding the natural history of COVID-19 disease contributing to the design and prioritization of clinical trials, and develop generalizable knowledge regarding patients who have been tested for COVID-19 and those at risk of developing the disease.
"HealthVerity is proud to support the FDA in strengthening the understanding of potential real-world data sources to address the proposed COVID-19 research questions and public-health use cases," said Andrew Kress, CEO at HealthVerity. "By identifying methods and processes to leverage this type of data for evidence generation, this collaboration builds on HealthVerity's provision of COVID-related data being used as part of separate COVID-19 research in progress by the FDA and Aetion."