FDA Collaboration on Real-world Datasets Post-Covid
FDA and HealthVerity have entered into a multi-year research collaboration agreement to evaluate a range of different real-world datasets for their potential to inform the agency’s response to Covid-19. Earlier this month, FDA commissioner Stephen Hahn said it is time to look forward and evaluate the agency’s response to identify new opportunities (see earlier story). Addressing the Alliance for a Stronger FDA in a virtual update, Hahn said FDA needs to learn from the work that is being done during the pandemic and apply that experience to the future. “Many policies and procedures were adjusted during the health emergency and it has become clear that a critical look at many traditional policies and processes is needed,” he said. “I've instructed my staff to identify lessons learned to permanently change these beyond the pandemic to make the agency more efficient.”
As the pandemic brought urgency to FDA’s efforts, available traditional data were used to grant emergency use authorizations (EUA) on the diagnostics and medical device side. Once the device gained market use, Hahn said FDA used real-world evidence, its Sentinel system and other resources to look back at the real-world use of some of the diagnostic tests and medical products and adjusted the EUAs based on that data.
Under the HealthVerity collaboration, FDA principal deputy commissioner Amy Abernethy says that 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.” The collaboration will leverage HealthVerity’s expertise in real-world data to help evaluate 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 company says.
According to HealthVerity, the research will 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 general knowledge about patients who have been tested for Covid-19 and those at risk of developing the disease.