A hierarchical testing approach for detecting safety signals in clinical trials.

Tan, Xianming; Chen, Bingshu E; Sun, Jianping; Patel, Tejendra; Ibrahim, Joseph G

Tan, Xianming; Chen, Bingshu E; Sun, Jianping; Patel, Tejendra; Ibrahim, Joseph G.

Afiliação

Tan X; Department of Biostatistics, UNC at Chapel Hill, Chapel Hill, North Carolina.
Chen BE; Canadian Cancer Trials Group and Department of Public Health Sciences, Queen's University, Kingston, Ontario, Canada.
Sun J; Department of Mathematics and Statistics, UNC at Greensboro, Greensboro, North Carolina.
Patel T; Division of Pharmacotherapy and Experimental Therapeutics, Eshelman School of Pharmacy, UNC at Chapel Hill, Chapel Hill, North Carolina.
Ibrahim JG; Department of Biostatistics, UNC at Chapel Hill, Chapel Hill, North Carolina.

Stat Med ; 39(10): 1541-1557, 2020 05 15.

Article em En | MEDLINE | ID: mdl-32050050

Assuntos

Simulação por Computador; Ensaios Clínicos como Assunto; Humanos

Palavras-chave

MiST; clinical trials; drug safety; hierarchical testing; multiplicity; signal detection

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Texto completo: 1 Bases de dados: MEDLINE Assunto principal: Simulação por Computador Tipo de estudo: Clinical_trials Limite: Humans Idioma: En Revista: Stat Med Ano de publicação: 2020 Tipo de documento: Article

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