Abstract
Evaluation of Publication of Pediatric Drug Trials
Highlights
Nonpublication of clinical trials compromises the integrity of scientific evidence and represents a breach in ethical obligations to trial participants.[1]
We performed a cross-sectional evaluation of pediatric trials registered in ClinicalTrials.gov
Trials were included if they examined a drug intervention in children younger than 18 years; had a randomized trial design; were registered between January 1, 2014, and June 30, 2016; and were completed or discontinued by June 30, 2018.3 This date was selected to allow a minimum of 2 years from trial end to publication of trial findings
Summary
Nonpublication of clinical trials compromises the integrity of scientific evidence and represents a breach in ethical obligations to trial participants.[1] Timely publication of trials in the medical literature is especially important for pediatric trials, which are often challenging to conduct because of small participant pools and unique ethical and practical considerations. Pediatric trials frequently fill critical gaps in medical knowledge. Many medications used in pediatric populations, for example, have not been formally tested in children; essential data on pediatric safety and efficacy are not available.[2] To increase our understanding of publication practices for pediatric studies, we assessed the rate of publication of pediatric drug trials. We examined the information that was lost when trials were not published
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