Transparency and Accountability of Pediatric Trials: Should Consent Rate Reporting Be Mandatory?

Transparency and Accountability of Pediatric Trials: Should Consent Rate Reporting Be Mandatory?
Editorial
Ana Marušić, Ivan Buljan
The Journal of Pediatrics, 1 December 2020; 227 pp 9-10
Excerpt
The study of Lonhart et al in this volume of The Journal sends a warning about reporting consent rates in pediatric trials.1 They analyzed 696 articles from MEDLINE presenting pediatric randomized controlled trials and showed that 60% (n = 418) of them did not report rates of consent for trial participants, or the consent rate was unclear. Among 278 trials that did report the number of consenting subjects, the average consent rate was high (83%), but for 26% of these trials, the average consent rate was less than 70%, which may introduce a bias related to the representativeness of the target population. Overall, the consent rates were greater for trials of vaccination interventions (90%) in comparison with behavioral interventions (79%), and for industry-funded trials (86%) in comparison with government-funded trials (79%). This study raises important questions related to the ethics of pediatric trials and to the quality and validity of evidence from pediatric trials…

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