Enhancing clarity of clinical trial safety reports for data monitoring committees.

Thomas, Sonia M; Jung, Kwanhye; Sun, Hengrui; Psioda, Matthew A; Quibrera, Pedro Miguel; Strakowski, Stephen M

Thomas, Sonia M; Jung, Kwanhye; Sun, Hengrui; Psioda, Matthew A; Quibrera, Pedro Miguel; Strakowski, Stephen M.

Afiliación

Thomas SM; Division of Biostatistics and Epidemiology, RTI International, Research Triangle Park, NC, USA.
Jung K; Collaborative Studies Coordinating Center, Department of Biostatistics, University of North Carolina, Chapel Hill, NC, USA.
Sun H; Division of Biometrics IV, Office of Biostatistics, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, MD, USA.
Psioda MA; Collaborative Studies Coordinating Center, Department of Biostatistics, University of North Carolina, Chapel Hill, NC, USA.
Quibrera PM; Collaborative Studies Coordinating Center, Department of Biostatistics, University of North Carolina, Chapel Hill, NC, USA.
Strakowski SM; Department of Psychiatry, Dell Medical School, University of Texas, Austin, TX, USA.

J Biopharm Stat ; 30(6): 1147-1161, 2020 11 01.

Article en En | MEDLINE | ID: mdl-32897808

Asunto(s)

Comités de Monitoreo de Datos de Ensayos Clínicos; Humanos

Palabras clave

Data monitoring committee; adverse event; clinical trial; data and safety monitoring board; graphical displays; incidence density; patient drop-out; safety data

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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Comités de Monitoreo de Datos de Ensayos Clínicos Límite: Humans Idioma: En Revista: J Biopharm Stat Asunto de la revista: FARMACOLOGIA Año: 2020 Tipo del documento: Article País de afiliación: Estados Unidos Pais de publicación: Reino Unido

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