Evaluation of diagnostic tests for low prevalence diseases: a statistical approach for leveraging real-world data to accelerate the study.

Chen, Wei-Chen; Li, Heng; Wang, Chenguang; Lu, Nelson; Song, Changhong; Tiwari, Ram; Xu, Yunling; Yue, Lilly Q

Chen, Wei-Chen; Li, Heng; Wang, Chenguang; Lu, Nelson; Song, Changhong; Tiwari, Ram; Xu, Yunling; Yue, Lilly Q.

Afiliação

Chen WC; Division of Biostatistics, Center for Devices and Radiological Health, U.S. Food and Drug Administration, Silver Spring, Maryland, USA.
Li H; Division of Biostatistics, Center for Devices and Radiological Health, U.S. Food and Drug Administration, Silver Spring, Maryland, USA.
Wang C; Division of Biostatistics and Bioinformatics, Sidney Kimmel Comprehensive Cancer Center, Johns Hopkins University, Baltimore, Maryland, USA.
Lu N; Division of Biostatistics, Center for Devices and Radiological Health, U.S. Food and Drug Administration, Silver Spring, Maryland, USA.
Song C; Division of Biostatistics, Center for Devices and Radiological Health, U.S. Food and Drug Administration, Silver Spring, Maryland, USA.
Tiwari R; Division of Biostatistics, Center for Devices and Radiological Health, U.S. Food and Drug Administration, Silver Spring, Maryland, USA.
Xu Y; Division of Biostatistics, Center for Devices and Radiological Health, U.S. Food and Drug Administration, Silver Spring, Maryland, USA.
Yue LQ; Division of Biostatistics, Center for Devices and Radiological Health, U.S. Food and Drug Administration, Silver Spring, Maryland, USA.

J Biopharm Stat ; 31(3): 375-390, 2021 05 04.

Article em En | MEDLINE | ID: mdl-33615997

Assuntos

Testes Diagnósticos de Rotina; Teorema de Bayes; Humanos; Prevalência; Pontuação de Propensão; Estudos Prospectivos

Palavras-chave

Real-world data; composite likelihood; diagnostic test; low prevalence diseases; power prior; propensity score; real-world evidence; sensitivity; specificity

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Texto completo: 1 Coleções: 01-internacional Base de dados: MEDLINE Assunto principal: Testes Diagnósticos de Rotina Tipo de estudo: Diagnostic_studies / Observational_studies / Prevalence_studies / Prognostic_studies / Risk_factors_studies Limite: Humans Idioma: En Revista: J Biopharm Stat Assunto da revista: FARMACOLOGIA Ano de publicação: 2021 Tipo de documento: Article País de afiliação: Estados Unidos

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