Please use this identifier to cite or link to this item: http://www.repositorio.ufop.br/jspui/handle/123456789/15986
Title: Exact sequential test for clinical trials and post-market drug and vaccine safety surveillance with Poisson and binary data.
Authors: Silva, Ivair Ramos
Maro, Judith
Kulldorff, Martin
Keywords: Adaptive design
Alpha spending
Continuous monitoring
Group sequential
Issue Date: 2021
Citation: SILVA, I. R.; MARO, J.; KULLDORFF, M. Exact sequential test for clinical trials and post-market drug and vaccine safety surveillance with Poisson and binary data. Statistics in Medicine, v. 40, n. 22, 2021. Disponível em: <https://onlinelibrary.wiley.com/doi/full/10.1002/sim.9094>. Acesso em: 06 jul. 2022.
Abstract: In sequential analysis, hypothesis testing is performed repeatedly in a prospective manner as data accrue over time to quickly arrive at an accurate conclusion or decision. In this tutorial paper, detailed explanations are given for both designing and operating sequential testing. We describe the calculation of exact thresholds for stopping or signaling, statistical power, expected time to signal, and expected sample sizes for sequential analysis with Poisson and binary type data. The calculations are run using the package Sequential, constructed in R language. Real data examples are inspired on clinical trials practice, such as the current efforts to develop treatments to face the COVID-19 pandemic, and the comparison of treatments of osteoporosis. In addition, we mimic the monitoring of adverse events following influenza vaccination and Pediarix vaccination.
URI: http://www.repositorio.ufop.br/jspui/handle/123456789/15986
metadata.dc.identifier.uri2: https://onlinelibrary.wiley.com/doi/full/10.1002/sim.9094
metadata.dc.identifier.doi: https://doi.org/10.1002/sim.9094
ISSN: 1097-0258
Appears in Collections:DEEST - Artigos publicados em periódicos

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