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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| Main Authors: | , , , , , , , , , , |
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| Format: | Artigo |
| Language: | Inglês |
| Published: |
BMJ Publishing Group
2019-12-01
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| Series: | BMJ Paediatrics Open |
| Online Access: | https://bmjpaedsopen.bmj.com/content/3/1/e000426.full |
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