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

• Glavni autori: Allison Gates (Autor), Patrina Caldwell (Autor), Sarah Curtis (Autor), Leonila Dans (Autor), Ricardo M Fernandes (Autor), Lisa Hartling (Autor), Lauren E Kelly (Autor), Katrina Williams (Autor), Kerry Woolfall (Autor), Michele P Dyson (Autor), Ben Vandermeer (Autor)
• Format: Knjiga
• Izdano: BMJ Publishing Group, 2019-12-01T00:00:00Z.
• Teme: article
• Online pristup: 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...