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stat.ME2023
Bayesian Safety Surveillance with Adaptive Bias Correction
Fan Bu, Martijn J. Schuemie, Akihiko Nishimura +7
Post-market safety surveillance is an integral part of mass vaccination programs. Typically relying on sequential analysis of real-world health data as they accrue, safety surveill…
stat.ME2022
Adjusting for both sequential testing and systematic error in safety surveillance using observational data: Empirical calibration and MaxSPRT
Martijn J. Schuemie, Fan Bu, Akihiko Nishimura +1
Post-approval safety surveillance of medical products using observational healthcare data can help identify safety issues beyond those found in pre-approval trials. When testing se…