Using the Bayesian detection of potential risk using inference on blinded safety data (BDRIBS) method to support the decision to refer an event for unblinded evaluation.

Waterhouse, Brian; Hartford, Alan; Mukhopadhyay, Saurabh; Ferguson, Ryan; Hendrickson, Barbara A

Waterhouse, Brian; Hartford, Alan; Mukhopadhyay, Saurabh; Ferguson, Ryan; Hendrickson, Barbara A.

Afiliação

Waterhouse B; Biostatistics and Research Decision Sciences, Merck Research Laboratories, Upper Gwynedd, Pennsylvania, USA.
Hartford A; Statistical & Quantitative Sciences, Takeda Pharmaceutical Co. Limited, Cambridge, Massachusetts, USA.
Mukhopadhyay S; Statistical Innovation, Data and Statistical Sciences, AbbVie Inc., North Chicago, Illinois, USA.
Ferguson R; Process Data Analytics, AbbVie, North Chicago, Illinois.
Hendrickson BA; Pharmacovigilance and Patient Safety, AbbVie, North Chicago, Illinois.

Pharm Stat ; 21(2): 372-385, 2022 03.

Article em En | MEDLINE | ID: mdl-34725911

Assuntos

Projetos de Pesquisa; Idoso; Teorema de Bayes; Humanos; Estados Unidos; United States Food and Drug Administration

Palavras-chave

BDRIBS; Bayesian inference; adverse events; blinded monitoring of safety data; clinical trial; safety; signal detection

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Texto completo: 1 Coleções: 01-internacional Base de dados: MEDLINE Assunto principal: Projetos de Pesquisa Tipo de estudo: Diagnostic_studies / Etiology_studies / Guideline / Prognostic_studies / Risk_factors_studies Limite: Aged / Humans País/Região como assunto: America do norte Idioma: En Revista: Pharm Stat Assunto da revista: FARMACOLOGIA Ano de publicação: 2022 Tipo de documento: Article País de afiliação: Estados Unidos

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