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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...
Autores principales: | , , , , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
BMJ Publishing Group
2019
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Materias: | |
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 |