CDISC, a clinical research data standards organization, has launched a task force to rapidly develop guidance on standardizing COVID-19 research data with the participation of several member companies.
This guidance will be released in the form of an Interim User Guide and will be made freely available on the CDISC website. Researchers around the world can leverage the User Guide to represent data in studies pertaining to COVID-19 to expedite the regulatory review process, reduce time to market, and drive operational efficiencies within their organizations. US FDA is aware of and observing the work of the task force.
As part of its work, the task force will also address controlled terminology necessary to represent changes in current inflight studies where patients acquire COVID-19 or where the ability to assess patient conditions are impacted by the pandemic. These best practices will be available to CDISC members.
Implementing CDISC standards allows data to be structured effectively and easily analyzed, leaving more time to focus on discoveries that will have invaluable impact on clinical research and global health, the organization said. Austin, Texas-based CDISC will leverage its existing work on virology and infectious disease therapeutic areas to expedite development.
“CDISC clinical data standards ensure that safe, effective pharmaceuticals and vaccines come to market faster,” said Peter Van Reusel, CDISC chief standards officer, in a statement. “We are utilizing all available resources to ensure standards of the highest quality are available for those researchers leading the effort to halt novel coronavirus. For this task force, we are bypassing our normal development timeline to ensure this User Guide is available within 45 days."