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

• Main Authors: Allison Gates (Author), Patrina Caldwell (Author), Sarah Curtis (Author), Leonila Dans (Author), Ricardo M Fernandes (Author), Lisa Hartling (Author), Lauren E Kelly (Author), Katrina Williams (Author), Kerry Woolfall (Author), Michele P Dyson (Author), Ben Vandermeer (Author)
• Format: Book
• Published: BMJ Publishing Group, 2019-12-01T00:00:00Z.
• Subjects: article
• Online Access: Connect to this object online.

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...