Updated analysis of pediatric clinical studies registered in ClinicalTrials.gov, 2008–2019

Abstract

Background Since the national clinical trials registry (ClinicalTrials.gov) launched in February 2000, more than 360,000 research studies in the United States and over 200 countries have registered. As the characteristics of pediatric clinical studies keep changing over time and the results-reporting mechanism is under evolving, to know about the relevant updates of data elements and the effect of policies on the quality of reporting results is significant. Methods In this research, 53,060 clinical studies related to children registered from January 2008 to December 2019 were downloaded from ClinicalTrials.gov on August 1st, 2020. Different types of studies and critical categorical variables were identified, based on which, Cochran-Armitage test was performed to explore temporal trend of study characteristics and common pediatric clinical conditions in four time subsets. Further, to examine heterogeneity among subgroups (funding sources, funding sites, pediatric clinical conditions,etc), chi-squared test was applied. Results A total of 36,136 clinical trials and 16,692 observational studies were identified during the study period. The pediatric clinical trials increased from 7,029 (January 2008–December 2010) to 11,738 (January 2017–December 2019). The number of missing data has declined, with the maximum extent decline from 3.7 to 0.0% (Z = − 15.90, p < 0.001). Drug trials decreased from 48.8 to 28.9% (Z = − 24.68, p < 0.001). Behavioral trials, on the other hand, increased from 12.6 to 20.4% (Z = 12.28, p < 0.001). Most pediatric clinical trials were small-scale (58.9% enrolling 1–100 participants), single-site (61.4%) and funded neither by industry nor by the NIH (59.2%). The proportion of reporting study results varied by study type (χ2 = 1,256.8, p < 0.001), lead sponsor (χ2 = 4,545.6, p < 0.001), enrollment (χ2 = 29.4, p < 0.001) and trial phase (χ2 = 218.8, p < 0.001). Conclusion Pediatric clinical studies registered in ClinicalTrials.gov were dominated by small-scale interventional trials, containing significant heterogeneity in funding sources, funding sites, pediatric clinical conditions and study characteristics. Although the results database has evolved in the past decade, efforts to strengthen the practice of systematic reporting must be continued.

Results Reporting and Early Termination of Childhood Obesity Trials Registered on ClinicalTrials.gov

“…Despite the policy of the International Council of Medical Journal Editors (ICMJE), which recommends that all investigators report results ( 38 ), we found that the quality of results reported in the childhood obesity registry is still poor. These conclusions are consistent with Yang et al ( 18 ). In clinical studies of mental health and neurology ( 30 , 39 ).…”

“…Previous studies have found that pediatric clinical trials are terminated frequently ( 19 , 20 , 26 ). Thousands of children have participated in these trials, which means considerable inefficiency and a waste of financial resources ( 18 ). However, the early termination rate of pediatric obesity trials (4.3%) was lower than that of neonatal clinical trials, pediatric cardiovascular trials, pediatric psychological trials, etc.…”

“…To identify pediatric clinical studies, we used the “Age Group: birth-17” criteria. In the retrieval studies, the Age Group field included three types: (Child), (Child, Adult) and (Child, Adult, Older Adult) ( 18 ). Records were downloaded on July 29, 2021, for all childhood obesity trials submitted to ClinicalTrials.gov .…”

“…Although a limited number of studies have cross-sectional descriptions of pediatric trials ( 18 – 20 ), they have not further identified the factors of unreported results and premature termination in pediatric obesity research. In addition, analyses of trial discontinuation and result reporting have primarily focused on adult populations, and the prevalence of these outcomes for pediatric randomized controlled trials (RCTs) remains less well defined ( 21 ).…”

Current situation of pediatric clinical trials in China: focus on trials for drug marketing application and administrative approval

“…gov and ChiCTR databases involved children in China, and the number of clinical trials for antineoplastic agents ( n = 254, 18.3%), anti-infectives ( n = 156, 11.2%) and vaccines ( n = 154, 11.1%) was the largest, it showed that distribution of the indications of the research drugs was quite different between drug registration trials and non- registration trials. Another research based on the ClinicalTrials.gov database showed nearly 53,000 trials related to children were registered from January 2008 to December 2019, indicating less than 14.7% of the registered trials involved children all over the word [ 20 ].…”