2021
DOI: 10.1002/pst.2148
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Assessing safety at the end of clinical trials using system organ classes: A case and comparative study

Abstract: Recent approaches to the statistical analysis of adverse event (AE) data in clinical trials have proposed the use of groupings of related AEs, such as by system organ class (SOC). These methods have opened up the possibility of scanning large numbers of AEs while controlling for multiple comparisons, making the comparative performance of the different methods in terms of AE detection and error rates of interest to investigators. We apply two Bayesian models and two procedures for controlling the false discover… Show more

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Cited by 5 publications
(2 citation statements)
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“…AE and SAEs were grouped by the organ class system ( 22 ). There were no prespecified futility margins for the DSMB; however, the DSMB was entitled to recommend termination of the study.…”
Section: Methodsmentioning
confidence: 99%
“…AE and SAEs were grouped by the organ class system ( 22 ). There were no prespecified futility margins for the DSMB; however, the DSMB was entitled to recommend termination of the study.…”
Section: Methodsmentioning
confidence: 99%
“…Bayesian modelling is used in a variety of different areas related to clinical trials such as adaptive designs, 10 meta-analyses 11 and assessing safety, 12 while we present a Bayesian framework that allows the probability distributions of the effect sizes of a group of related combination therapies to be updated based on the outcome of a single combination study. This allows the PoS of related combination studies to be updated.…”
Section: Introductionmentioning
confidence: 99%