ArticleBMC pediatrics2025
Comparison of the completed and discontinued pediatric drug clinical trials in Mainland China: a cross-sectional analysis based on the data from 2003 to 2023.
Article in BMC pediatrics, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
1 citing paper in PubMed.
- Characteristics, accessibility and regional equity evaluation of pediatric medicines through National Drug Price Negotiation of China, 2017-2024.Frontiers in pharmacology · 2026Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
3 authors.
Funding
Abstract
backgroundPediatric drug clinical trials are essential for ensuring the accessibility and safety of medications intended for children. In recent years, the Chinese government has implemented various measures to foster the development of pediatric drug clinical trials, and these efforts have yielded noticeable results. This study analyzed pediatric drug trial data from ClinicalTrials.gov and the Drug Clinical Trial Registration and Information Publication Platform. Its primary purpose was to discuss the issues and challenges faced by pediatric drug clinical trials in China and propose potential solutions.
methodsThis study conducted a cross-sectional analysis of concluded pediatric drug clinical trials (completed or discontinued) in mainland China from 2003 to 2023. Descriptive statistics were performed on the included data, and both univariate subgroup analysis and binary logistic regression were utilized to analyze the factors influencing completion duration and trial discontinuation.
resultsA total of 722 concluded pediatric drug clinical trials were extracted, with the overall number increasing annually at an average annual growth rate of 21.5%. We found that there existed imbalance in various aspects such as drug type, diseases, age, and the types and distribution of trial institutions. The analysis of trial durations indicated a progressive reduction in the completion cycles of pediatric drug clinical trials conducted in China, with notable variations across different subgroups. Four variables-trial size, the establishment of Data Monitoring Committees (DMCs), control type, and disease-exerted significant influence on the discontinuation of pediatric drug clinical trials. The primary reasons for trial discontinuation are issues related to safety or efficacy as reflected in trial outcomes (27.2%), as well as adjustments in commercial strategies or trial plans (24.6%).
conclusionsDespite the ongoing increase in the number of pediatric drug clinical trials in China, significant challenges and imbalances persist across various dimensions. To enhance the quality and efficiency of these trials and collectively advance pediatric drug research and development, it is imperative to refine the existing legal and regulatory frameworks, promote the professionalization and standardization of pediatric drug clinical trials, bolster the application of emerging methods and technologies, such as seamless design and artificial intelligence.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.