US FDA Invites Randomized Trial Designs With Real-World Elements
Agency is eager to engage with sponsors on ‘well thought-out proposals' to include real-world data sources in randomized studies, Office of New Drugs director Peter Stein says but adds that believability and robustness of the data are the agency’s primary concern.
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FDA's principal deputy commissioner, who used to work in the real-world evidence field, said momentum is building, but more successful use cases are needed.
The concept of missing data is very different when analyzing real-world evidence compared to a randomized clinical trial.
Agency’s approach to assessing real-world evidence for effectiveness will be guided by three key principles: fitness for use of the underlying data, adequacy of the study design, and satisfactory monitoring and data collection.