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

ABSTRACT:

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 process of the blinded investigator identifying a potential safety signal, which should be further investigated by the Data and Safety Monitoring Board with an unblinded safety data analysis.

Methods

In this paper, two-stage Bayesian hierarchical models are proposed for safety signal detection following a pre-specified set of interim analyses that are applied to efficacy. At stage 1, a hierarchical blinded model uses blinded safety data to detect a potential safety signal and at stage

SUBMITTER: Liu J 

PROVIDER: S-EPMC7433072 | biostudies-literature | 2020 Aug

REPOSITORIES: biostudies-literature