Two-stage Bayesian hierarchical modeling for blinded and unblinded safety monitoring in randomized clinical trials.
Junhao LiuJo WickRenee' H MartinCaitlyn MeinzerDooti RoyRichard J BarohnPublished in: BMC medical research methodology (2020)
The two-stage Bayesian safety procedure in this paper provides a statistical view to monitor safety during the clinical trials. The proposed two-stage monitoring model has an excellent accuracy of detecting and flagging a potential safety signal at stage 1, and with the most important feature that further action at stage 2 could confirm the safety issue.