{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,8,19]],"date-time":"2026-08-19T06:27:30Z","timestamp":1787120850584,"version":"build-2736575974"},"reference-count":27,"publisher":"Frontiers Media SA","license":[{"start":{"date-parts":[[2026,8,19]],"date-time":"2026-08-19T00:00:00Z","timestamp":1787097600000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"content-domain":{"domain":["frontiersin.org"],"crossmark-restriction":true},"short-container-title":["Front. Pharmacol."],"abstract":"<jats:sec>\n                    <jats:title>Objective<\/jats:title>\n                    <jats:p>\n                      To characterize the registration characteristics of investigator-initiated pediatric drug trials (IITs) conducted in Chinese children\u2019s hospitals and compare registration patterns between ChiCTR and\n                      <jats:ext-link>ClinicalTrials.gov<\/jats:ext-link>\n                      , thereby providing evidence to support future pediatric drug clinical research.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>\n                      Pediatric interventional trial registrations were retrieved from ChiCTR and\n                      <jats:ext-link>ClinicalTrials.gov<\/jats:ext-link>\n                      from database inception to December 31, 2024. Eligible studies met the following inclusion criteria: participants aged &amp;lt;18 years, interventions involving pediatric medicines, research sites including children\u2019s hospitals, and studies meeting the criteria for IITs.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>\n                      A total of 749 registrations of pediatric drug-related IITs were included, including 527 from ChiCTR and 222 from\n                      <jats:ext-link>ClinicalTrials.gov<\/jats:ext-link>\n                      . The number of pediatric drug-related IIT registrations conducted in Chinese children\u2019s 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.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusion<\/jats:title>\n                    <jats:p>Although registrations of pediatric drug-related IITs conducted in Chinese children\u2019s 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.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.3389\/fphar.2026.1907190","type":"journal-article","created":{"date-parts":[[2026,8,19]],"date-time":"2026-08-19T05:45:58Z","timestamp":1787118358000},"update-policy":"https:\/\/doi.org\/10.3389\/crossmark-policy","source":"Crossref","is-referenced-by-count":0,"title":["Characteristics of pediatric drug-related investigator-initiated trials in Chinese children\u2019s hospitals: a comparative analysis based on ChiCTR and ClinicalTrials.gov registration data"],"prefix":"10.3389","volume":"17","author":[{"given":"Yong","family":"Yang","sequence":"first","affiliation":[{"name":"Health Economic and Management College, Nanjing University of Chinese Medicine","place":["Nanjing, China"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Dailei","family":"Zhang","sequence":"additional","affiliation":[{"name":"Health Economic and Management College, Nanjing University of Chinese Medicine","place":["Nanjing, China"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Shanshi","family":"Yang","sequence":"additional","affiliation":[{"name":"Shanghai Health Development Research Center (Shanghai Medical Information Center)","place":["Shanghai, China"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Zhengrong","family":"Yao","sequence":"additional","affiliation":[{"name":"School of Nursing, Nanjing University of Chinese Medicine","place":["Nanjing, China"]}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"1965","published-online":{"date-parts":[[2026,8,19]]},"reference":[{"key":"B1","unstructured":"21 CFR 312.3: definitions and interpretations"},{"key":"B2","unstructured":"Rare diseases at FDA"},{"key":"B3","doi-asserted-by":"publisher","first-page":"361","DOI":"10.1016\/S0140-6736(19)33220-9","article-title":"Compliance with legal requirement to report clinical trial results on ClinicalTrials.gov: a cohort study","volume":"395","author":"DeVito","year":"2020","journal-title":"Lancet"},{"key":"B4","doi-asserted-by":"publisher","first-page":"2431","DOI":"10.3390\/pharmaceutics15102431","article-title":"Pediatric drug development: reviewing challenges and opportunities by tracking innovative therapies","volume":"15","author":"Domingues","year":"2023","journal-title":"Pharmaceutics"},{"key":"B5","unstructured":"Clinical trials registration\n          \n          \n          2026"},{"key":"B6","doi-asserted-by":"publisher","first-page":"1927","DOI":"10.3969\/j.issn.1003-3734.2024.18.010","article-title":"Study on subject protection in clinical trials of pediatric drugs: from the perspective of ethical review","volume":"33","author":"Fang","year":"2024","journal-title":"Chin. J. New Drugs"},{"key":"B7","doi-asserted-by":"publisher","first-page":"878","DOI":"10.13288\/j.11-2166\/r.2025.09.002","article-title":"Current status and optimization strategies for investigator-initiated trial on traditional Chinese medicine in the treatment of malignant tumors conducted by western medicine institutions","volume":"66","author":"Geng","year":"2025","journal-title":"J. Tradit. Chin. Med."},{"key":"B8","doi-asserted-by":"publisher","first-page":"1069933","DOI":"10.3389\/fmed.2022.1069933","article-title":"Academic clinical trials: publication of study results on an international registry-We can do better","volume":"9","author":"Hoffmann","year":"2022","journal-title":"Front. Med. (Lausanne)"},{"key":"B9","doi-asserted-by":"publisher","first-page":"797","DOI":"10.20251\/j.cnki.1003-3734.2025.08.003","article-title":"Research on the history and effect of incentive policy for pediatric drug development in China","volume":"34","author":"Huang","year":"2025","journal-title":"Chin. J. New Drugs"},{"key":"B10","unstructured":"E8(R1): general considerations for clinical studies\n          \n          \n          2021"},{"key":"B11","doi-asserted-by":"publisher","first-page":"1172","DOI":"10.7507\/1672-2531.202303197","article-title":"Analysis of registered industry-sponsored clinical trials of pediatric drugs in China","volume":"23","author":"Jiang","year":"2023","journal-title":"Chin. J. Evid. Based Med."},{"key":"B12","doi-asserted-by":"publisher","first-page":"2047","DOI":"10.1016\/S0140-6736(22)00478-0","article-title":"Global, regional, and national disease burden estimates of acute lower respiratory infections due to respiratory syncytial virus in children younger than 5 years in 2019: a systematic analysis","volume":"399","author":"Li","year":"2022","journal-title":"Lancet"},{"key":"B13","doi-asserted-by":"publisher","first-page":"1345","DOI":"10.20251\/j.cnki.1003-3734.2025.13.001","article-title":"An analysis of the development achievements in pediatric drugs in China driven by policy","volume":"34","author":"Liang","year":"2025","journal-title":"Chin. J. New Drugs."},{"key":"B14","article-title":"United nations children\u2019s fund (UNICEF), united nations population fund (UNFPA)","volume-title":"Children in China: Facts and Figures 2020","year":"2023"},{"key":"B15","unstructured":"Administrative measures for investigator-initiated clinical research in medical institutions\n          \n          \n          2023"},{"key":"B16","volume-title":"China Health Statistics Yearbook 2024","year":"2026"},{"key":"B17","unstructured":"WHO international clinical trials registry platform (ICTRP)\n          \n          \n            \n              Organization\n              W. H.\n            \n          \n          \n          2026"},{"key":"B18","doi-asserted-by":"publisher","first-page":"1","DOI":"10.1038\/s43586-022-00100-2","article-title":"Designing clinical trials for rare diseases: unique challenges and opportunities","volume":"2","author":"Pizzamiglio","year":"2022","journal-title":"Nat. Rev. Methods Prim."},{"key":"B19","doi-asserted-by":"publisher","first-page":"93","DOI":"10.1038\/s41573-019-0049-9","article-title":"Therapies for rare diseases: therapeutic modalities, progress and challenges ahead","volume":"19","author":"Tambuyzer","year":"2020","journal-title":"Nat. Rev. Drug Discov."},{"key":"B20","volume-title":"E11(R1) Addendum: Clinical Investigation of Medicinal Products in the Pediatric Population","year":"2018"},{"key":"B21","doi-asserted-by":"publisher","first-page":"149","DOI":"10.6039\/j.issn.1001-0408.2019.02.02","article-title":"Problems of clinical use in pediatric drugs and countermeasure analysis in China","volume":"30","author":"Wang","year":"2019","journal-title":"China Pharm."},{"key":"B22","doi-asserted-by":"publisher","first-page":"1571","DOI":"10.16522\/j.cnki.cjph.2022.11.007","article-title":"General considerations and suggestions for pharmaceutical research and development of pharmaceutical preparations of traditional Chinese medicine for children","volume":"53","author":"Wang","year":"2022","journal-title":"Chin. J. Pharm."},{"key":"B23","doi-asserted-by":"publisher","first-page":"424","DOI":"10.3760\/cma.j.cn113565-20240131-00038","article-title":"Discussion on implementation risks and countermeasures of investigator-initiated pediatric drug clinical trials based on drug management","volume":"37","author":"Ye","year":"2024","journal-title":"Chin. J. Med. Sci. Res. Manag."},{"key":"B24","doi-asserted-by":"publisher","first-page":"1345969","DOI":"10.3389\/fped.2023.1345969","article-title":"Pharmacokinetic and pharmacodynamic principles: unique considerations for optimal design of neonatal clinical trials","volume":"11","author":"Yeung","year":"2023","journal-title":"Front. Pediatr."},{"key":"B25","doi-asserted-by":"publisher","first-page":"412","DOI":"10.3892\/etm.2024.12701","article-title":"Off-label and unapproved pediatric drug utilization: a meta-analysis","volume":"28","author":"Yuan","year":"2024","journal-title":"Exp. Ther. Med."},{"key":"B26","doi-asserted-by":"publisher","first-page":"1998","DOI":"10.1056\/NEJMsr1611785","article-title":"Trial reporting in clinicalTrials.gov - the final rule","volume":"375","author":"Zarin","year":"2016","journal-title":"N. Engl. J. Med."},{"key":"B27","doi-asserted-by":"publisher","first-page":"132","DOI":"10.12376\/j.issn.2097-0501.2025.01.017","article-title":"Compliance risk management of investigator initiated trials on children rare diseases: medical institution perspective","volume":"4","author":"Zhang","year":"2025","journal-title":"J. Rare Dis."}],"container-title":["Frontiers in Pharmacology"],"original-title":[],"link":[{"URL":"https:\/\/www.frontiersin.org\/articles\/10.3389\/fphar.2026.1907190\/full","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2026,8,19]],"date-time":"2026-08-19T05:46:11Z","timestamp":1787118371000},"score":1,"resource":{"primary":{"URL":"https:\/\/www.frontiersin.org\/articles\/10.3389\/fphar.2026.1907190\/full"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2026,8,19]]},"references-count":27,"alternative-id":["10.3389\/fphar.2026.1907190"],"URL":"https:\/\/doi.org\/10.3389\/fphar.2026.1907190","relation":{},"ISSN":["1663-9812"],"issn-type":[{"value":"1663-9812","type":"electronic"}],"subject":[],"published":{"date-parts":[[2026,8,19]]},"article-number":"1907190"}}