Adjusting for both sequential testing and systematic error in safety surveillance using observational data: Empirical calibration and MaxSPRT

Post‐approval safety surveillance of medical products using observational healthcare data can help identify safety issues beyond those found in pre‐approval trials. When testing sequentially as data accrue, maximum sequential probability ratio testing (MaxSPRT) is a common approach to maintaining no...

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Detalles Bibliográficos
Autores principales: Schuemie, Martijn J., Bu, Fan, Nishimura, Akihiko, Suchard, Marc A.
Formato: Online Artículo Texto
Lenguaje:English
Publicado: John Wiley & Sons, Inc. 2023
Materias:
Research Articles
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10107810/
https://www.ncbi.nlm.nih.gov/pubmed/36642826
http://dx.doi.org/10.1002/sim.9631

Internet

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10107810/
https://www.ncbi.nlm.nih.gov/pubmed/36642826
http://dx.doi.org/10.1002/sim.9631

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