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

BACKGROUND: Monitoring and reporting of drug safety during a clinical trial is essential to its success. More recent attention to drug safety has encouraged statistical methods development for monitoring and detecting potential safety signals. This paper investigates the potential impact of the proc...

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Bibliografiske detaljer
Udgivet i:BMC Med Res Methodol
Main Authors: Liu, Junhao, Wick, Jo, Martin, Renee’ H., Meinzer, Caitlyn, Roy, Dooti, Gajewski, Byron
Format: Artigo
Sprog:Inglês
Udgivet: BioMed Central 2020
Fag:
Online adgang:https://ncbi.nlm.nih.gov/pmc/articles/PMC7433072/
https://ncbi.nlm.nih.gov/pubmed/32807102
https://ncbi.nlm.nih.govhttp://dx.doi.org/10.1186/s12874-020-01097-6
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