Please use this identifier to cite or link to this item:
http://www.repositorio.ufop.br/jspui/handle/123456789/9401
Title: | Type I error probability spending for post–market drug and vaccine safety surveillance with binomial data. |
Authors: | Silva, Ivair Ramos |
Keywords: | Expected time to signal Score statistic Sequential probability ratio test |
Issue Date: | 2017 |
Citation: | SILVA, I. R. Type I error probability spending for post–market drug and vaccine safety surveillance with binomial data. Statistics in Medicine, v. 01, p. 1-12, 2017. Disponível em: <http://onlinelibrary.wiley.com/doi/10.1002/sim.7504/full>. Acesso em: 16 jan. 2018. |
Abstract: | Type I error probability spending functions are commonly used for designing sequential analysis of binomial data in clinical trials, but it is also quickly emerging for near–continuous sequential analysis of post–market drug and vaccine safety surveillance. It iswell known that, for clinical trials,when the null hypothesis is not rejected, it is still important to minimize the sample size. Unlike in post–market drug and vaccine safety surveillance, that is not important. In post–market safety surveillance, specially when the surveillance involves identification of potential signals, the meaningful statistical performance measure to be minimized is the expected sample size when the null hypothesis is rejected. The present paper shows that, instead of the convex Type I error spending shape conventionally used in clinical trials, a concave shape is more indicated for post–market drug and vaccine safety surveillance. This is shown for both, continuous and group sequential analysis. |
URI: | http://www.repositorio.ufop.br/handle/123456789/9401 |
metadata.dc.identifier.uri2: | http://onlinelibrary.wiley.com/doi/10.1002/sim.7504/full |
metadata.dc.identifier.doi: | https://doi.org/10.1002/sim.7504 |
ISSN: | 1097-0258 |
Appears in Collections: | DEEST - Artigos publicados em periódicos |
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ARTIGO_TypeIError.pdf Restricted Access | 768,97 kB | Adobe PDF | View/Open |
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