Alpha spending for historical versus surveillance Poisson data with CMaxSPRT.

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MetadadosDescriçãoIdioma
Autor(es): dc.creatorSilva, Ivair Ramos-
Autor(es): dc.creatorLopes, Wilson Araujo-
Autor(es): dc.creatorDias, Philipe-
Autor(es): dc.creatorYih, W. Katherine-
Data de aceite: dc.date.accessioned2025-08-21T15:52:54Z-
Data de disponibilização: dc.date.available2025-08-21T15:52:54Z-
Data de envio: dc.date.issued2019-06-06-
Data de envio: dc.date.issued2019-06-06-
Data de envio: dc.date.issued2019-
Fonte completa do material: dc.identifierhttp://www.repositorio.ufop.br/handle/123456789/11458-
Fonte completa do material: dc.identifierhttps://onlinelibrary.wiley.com/doi/10.1002/sim.8097-
Fonte completa do material: dc.identifierhttps://doi.org/10.1002/sim.8097-
Fonte: dc.identifier.urihttp://educapes.capes.gov.br/handle/capes/1026426-
Descrição: dc.descriptionSequential analysis hypothesis testing is now an important tool for postmarket drug and vaccine safety surveillance. When the number of adverse events accruing in time is assumed to follow a Poisson distribution, and if the baseline Poisson rate is assessed only with uncertainty, the conditional maximized sequential probability ratio test, CMaxSPRT, is a formal solution. CMaxSPRT is based on comparing monitored data with historical matched data, and it was primarily developed under a flat signaling threshold. This paper demonstrates that CMaxSPRT can be performed under nonflat thresholds too.We pose the discussion in the light of the alpha spending approach. In addition, we offer a rule of thumb for establishing the best shape of the signaling threshold in the sense of minimizing expected time to signal and expected sample size. An example involving surveillance for adverse events after influenza vaccination is used to illustrate the method.-
Formato: dc.formatapplication/pdf-
Idioma: dc.languageen-
Direitos: dc.rightsrestrito-
Palavras-chave: dc.subjectClinical trials-
Palavras-chave: dc.subjectPostmarket vaccine safety surveillance-
Palavras-chave: dc.subjectSample size-
Palavras-chave: dc.subjectTime to signal-
Título: dc.titleAlpha spending for historical versus surveillance Poisson data with CMaxSPRT.-
Aparece nas coleções:Repositório Institucional - UFOP

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