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Fig. 1 | BMC Medical Research Methodology

Fig. 1

From: Two-stage Bayesian hierarchical modeling for blinded and unblinded safety monitoring in randomized clinical trials

Fig. 1

The flowchart of the Two-stage Bayesian safety monitoring for blinded and unblinded data. The figure displays the process of Two-stage Bayesian hierarchical monitoring, which starts with collecting the number of reported AE subjects in the pooled data, then goes through the Bayesian hierarchical blinded model to detect the potential safety signals at stage 1 for blinded safety data. Then, the Bayesian hierarchical logistic model is implemented to confirm the safety issue after the safety data being unblinded at stage 2

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