Data monitoring committees in pediatric randomized controlled trials registered in ClinicalTrials.gov.

ABSTRACT:

Background

Data monitoring committees advise on clinical trial conduct through appraisal of emerging data to ensure participant safety and scientific integrity. While consideration of their use is recommended for trials performed with vulnerable populations, previous research has shown that data monitoring committees are reported infrequently in publications of pediatric randomized controlled trials. We aimed to assess the frequency of reported data monitoring committee adoption in ClinicalTrials.gov registry records and to examine the influence of key trial characteristics.

Methods

We conducted a cross-sectional data analysis of all randomized controlled trials performed exclusively in a pediatric population and registered in ClinicalTrials.gov between 2008 and 2021. We use

SUBMITTER: Machado T 

PROVIDER: S-EPMC10638853 | biostudies-literature | 2023 Dec

REPOSITORIES: biostudies-literature