Non-Interventional Studies Guidance

FDA has published a draft guidance, Real-World Evidence: Considerations Regarding Non-Interventional Studies for Drug and Biological Products, with recommendations for sponsors and investigators who are considering submitting a non-interventional study to the agency to contribute to a demonstration of substantial evidence of effectiveness and/or evidence of the safety of a drug. The document specifically discusses attributes regarding the design and analysis of a non-interventional study that sponsors should consider when proposing a non-interventional study for such regulatory purposes.

“The reliability and relevance of real-world data used in a non-interventional study are critical for making appropriate causal inferences and are essential to establishing the data’s fitness for use in generating real-world evidence to support a labeling change or address a safety concern,” the guidance says.