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Reporting of data monitoring committees and adverse events in paediatric trials: a descriptive analysis

OBJECTIVES: For 300 paediatric trials, we evaluated the reporting of: a data monitoring committee (DMC); interim analyses, stopping rules and early stopping; and adverse events and harm-related endpoints. METHODS: For this cross-sectional evaluation, we randomly selected 300 paediatric trials publis...

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Detalles Bibliográficos
Autores principales:	Gates, Allison, Caldwell, Patrina, Curtis, Sarah, Dans, Leonila, Fernandes, Ricardo M, Hartling, Lisa, Kelly, Lauren E, Vandermeer, Ben, Williams, Katrina, Woolfall, Kerry, Dyson, Michele P
Formato:	Online Artículo Texto
Lenguaje:	English
Publicado:	BMJ Publishing Group 2019
Materias:	Evidence Based Medicine
Acceso en línea:	https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6542427/ https://www.ncbi.nlm.nih.gov/pubmed/31206076 http://dx.doi.org/10.1136/bmjpo-2018-000426

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