Characteristics of pediatric drug-related investigator-initiated trials in Chinese children’s hospitals: a comparative analysis based on ChiCTR and ClinicalTrials.gov registration data

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Objective: To characterize the registration characteristics of investigator-initiated pediatric drug trials (IITs) conducted in Chinese children's hospitals and compare registration patterns between ChiCTR and ClinicalTrials.gov, thereby providing evidence to support future pediatric drug clinical research. Methods: Pediatric interventional trial registrations were retrieved from ChiCTR and ClinicalTrials.gov from database inception to December 31, 2024. Eligible studies met the following inclusion criteria: participants aged <18 years, interventions involving pediatric medicines, research sites including children's hospitals, and studies meeting the criteria for IITs. Results: A total of 749 registrations of pediatric drug-related IITs were included, including 527 from ChiCTR and 222 from ClinicalTrials.gov. The number of pediatric drug-related IIT registrations conducted in Chinese children's hospitals showed an overall increasing trend. The included trials primarily involved infants, children, and adolescents, with exploratory trials/preliminary studies and post-marketing drug studies representing the predominant research stages. Geographic distribution patterns differed between the two databases, and international multicenter trials remained limited. Chemical drugs and biological products were the predominant drug categories, whereas studies involving traditional Chinese medicines/natural products were relatively insufficient. Conclusion: Although registrations of pediatric drug-related IITs conducted in Chinese children's hospitals have increased in recent years, imbalances remain in the distribution of study populations, drug categories, disease areas, and research institutions. Further efforts are needed to strengthen multicenter collaboration and establish supportive systems for pediatric clinical research, thereby facilitating the accumulation of evidence for pediatric medication evaluation.

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