As the US FDA grapples with how to use real-world data for regulatory decisions, two FDA officials wrote in a perspective published last Friday in the Clinical Journal of the American Society of Nephrology that the agency is developing guidance on data quality issues unique to the real-world data setting and related study design considerations. New data standards will need to be developed and FDA is “currently exploring,” they write, when the use of observational data “may be appropriate for evaluating effectiveness from a broad policy perspective and also, as individual drug manufacturers submit proposals for using real world data to support marketing applications.” Learn More