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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 published...

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Principais autores: Allison Gates, Patrina Caldwell, Sarah Curtis, Leonila Dans, Ricardo M Fernandes, Lisa Hartling, Lauren E Kelly, Katrina Williams, Kerry Woolfall, Michele P Dyson, Ben Vandermeer
Formato: Artigo
Idioma:Inglês
Publicado em: BMJ Publishing Group 2019-12-01
coleção:BMJ Paediatrics Open
Acesso em linha:https://bmjpaedsopen.bmj.com/content/3/1/e000426.full
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