9 September 2019 - 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.

Aliza Thompson and Mary Ross Southworth of the Division of Cardiovascular and Renal Products within FDA’s Center for Drug Evaluation and Research (CDER) explain: “Although the FDA has experience using observational (non-interventional) study designs in the post-market setting to evaluate product risks in broad populations, using non-randomised methodologies to determine effectiveness can be problematic because of concerns about the ability to adequately control for confounding, selection bias, and the possibility of misclassification error.”

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