Exploring the publication gap in pediatric randomized clinical
trials: completed vs. uncompleted pediatric clinical trials

J 2025

Exploring the publication gap in pediatric randomized clinical trials: completed vs. uncompleted pediatric clinical trials

NEBESKÁ, Kateřina; Lenka SOUČKOVÁ; Radka ŠTĚPÁNOVÁ a Regina DEMLOVÁ

Základní údaje

Originální název

Exploring the publication gap in pediatric randomized clinical trials: completed vs. uncompleted pediatric clinical trials

Autoři

NEBESKÁ, Kateřina; Lenka SOUČKOVÁ; Radka ŠTĚPÁNOVÁ a Regina DEMLOVÁ

Vydání

Frontiers in Medicine, LAUSANNE, FRONTIERS MEDIA SA, 2025, 2296-858X

Další údaje

Jazyk

angličtina

Typ výsledku

Článek v odborném periodiku

Obor

30230 Other clinical medicine subjects

Stát vydavatele

Švýcarsko

Utajení

není předmětem státního či obchodního tajemství

Odkazy

URL

Impakt faktor

Impact factor: 3.000 v roce 2024

Označené pro přenos do RIV

Ano

Kód RIV

RIV/00216224:14110/25:00141521

Organizační jednotka

Lékařská fakulta

Klíčová slova anglicky

registry; clinical trials; pediatrics; results; publication bias

Štítky

14110516, 14119710, rivok

Příznaky

Mezinárodní význam, Recenzováno

Změněno: 7. 7. 2025 12:44, Mgr. Tereza Miškechová

Anotace

V originále

Background Randomized clinical trials (RCTs) are essential for advancing medical knowledge, especially in pediatrics, where they provide critical evidence for safe and effective treatments. Regulatory frameworks like the Pediatric Regulation in the EU and the Best Pharmaceuticals for Children Act in the U.S. have spurred growth in pediatric RCTs. However, these clinical trials face unique challenges, including ethical complexities, recruitment difficulties, and funding limitations, which can hinder their completion. The publication of RCTs' results is equally crucial, yet not all completed RCTs share their findings, contributing to publication bias. This bias, especially in pediatric clinical trials, can distort medical evidence, impact clinical decisions, and potentially compromise patient safety.Methods We conducted a cross-sectional analysis of pediatric RCTs registered on ClinicalTrials.gov between 2011 and 2013, with completion status by 2017. Inclusion criteria included clinical trials with drug interventions in participants aged 0-17 and randomization. Data on RCTs characteristics, including phase, funding source, participant age, and enrollment, were extracted. RCTs completion status was assessed, and reasons for incompletion were categorized. Publication status was evaluated through registry and manual searches on PubMed and Google Scholar. Statistical analyses, including logistic regression, were performed to identify factors associated with trial incompletion and non-publication.Results Out of 2875 pediatric clinical trials reviewed, 1088 met the inclusion criteria. Among these, 16.54% were uncompleted, primarily due to patient accrual issues (32.22%). Academic sponsors funded 48.53% of trials, and industrial sponsors funded 45.13%. Of 908 completed RCTs, 58.48% posted results in registries, while 70% had results published in peer-reviewed journals. Industrially funded RCTs were more likely to post results, but academic RCTs had a higher scientific publication rate. The median time to first result publication in registries was 21 months, with significant delays linked to the trial phase, funding, and participant enrolment size.Conclusion Our study highlights significant challenges in pediatric RCTs, including high incompletion rates and delays in result reporting. Ethical, regulatory, and logistical barriers hinder progress, impacting evidence transparency. Strengthened regulatory oversight and enhanced compliance are essential to improve pediatric research outcomes and ensure timely dissemination of RCTs results.

Návaznosti

CZ.02.1.01/0.0/0.0/16_013/0001826, interní kód MU
(Kód CEP: EF16_013/0001826)

Název: CZECRIN_PRO PACIENTY - zavádění inovativních moderních terapií

Investor: Ministerstvo školství, mládeže a tělovýchovy ČR, CZECRIN_PRO PACIENTY - zavádění inovativních moderních terapií, PO 1 Posilování kapacit pro kvalitní výzkum

LM2023049, projekt VaV

Název: Český národní uzel Evropské sítě infrastruktur klinického výzkumu

Investor: Ministerstvo školství, mládeže a tělovýchovy ČR, CZECRIN - Czech National Node to the European Clinical Research Infrastructure Network

MUNI/A/1722/2024, interní kód MU

Název: Specifický farmakologický výzkum v oblasti farmakokinetiky, behaviorální neuropsychofarmakologie a personalizované farmakoterapie v onkologii

Investor: Masarykova univerzita, Specifický farmakologický výzkum v oblasti farmakokinetiky, behaviorální neuropsychofarmakologie a personalizované farmakoterapie v onkologii

Citovat

NEBESKÁ, Kateřina; Lenka SOUČKOVÁ; Radka ŠTĚPÁNOVÁ a Regina DEMLOVÁ. Exploring the publication gap in pediatric randomized clinical trials: completed vs. uncompleted pediatric clinical trials. Frontiers in Medicine. LAUSANNE: FRONTIERS MEDIA SA, 2025, roč. 12, May 2025, s. 1-13. ISSN 2296-858X. Dostupné z: https://doi.org/10.3389/fmed.2025.1590125.

@article{2507562,
   author = {Nebeská, Kateřina and Součková, Lenka and Štěpánová, Radka and Demlová, Regina},
   article_location = {LAUSANNE},
   article_number = {May 2025},
   doi = {https://doi.org/10.3389/fmed.2025.1590125},
   keywords = {registry; clinical trials; pediatrics; results; publication bias},
   language = {eng},
   issn = {2296-858X},
   journal = {Frontiers in Medicine},
   title = {Exploring the publication gap in pediatric randomized clinical trials: completed vs. uncompleted pediatric clinical trials},
   url = {https://www.frontiersin.org/journals/medicine/articles/10.3389/fmed.2025.1590125/full},
   volume = {12},
   year = {2025}
}

TY  - JOUR
ID  - 2507562
AU  - Nebeská, Kateřina - Součková, Lenka - Štěpánová, Radka - Demlová, Regina
PY  - 2025
TI  - Exploring the publication gap in pediatric randomized clinical trials: completed vs. uncompleted pediatric clinical trials
JF  - Frontiers in Medicine
VL  - 12
IS  - May 2025
SP  - 1-13
EP  - 1-13
PB  - FRONTIERS MEDIA SA
SN  - 2296858X
KW  - registry
KW  - clinical trials
KW  - pediatrics
KW  - results
KW  - publication bias
UR  - https://www.frontiersin.org/journals/medicine/articles/10.3389/fmed.2025.1590125/full
N2  - Background Randomized clinical trials (RCTs) are essential for advancing medical knowledge, especially in pediatrics, where they provide critical evidence for safe and effective treatments. Regulatory frameworks like the Pediatric Regulation in the EU and the Best Pharmaceuticals for Children Act in the U.S. have spurred growth in pediatric RCTs. However, these clinical trials face unique challenges, including ethical complexities, recruitment difficulties, and funding limitations, which can hinder their completion. The publication of RCTs' results is equally crucial, yet not all completed RCTs share their findings, contributing to publication bias. This bias, especially in pediatric clinical trials, can distort medical evidence, impact clinical decisions, and potentially compromise patient safety.Methods We conducted a cross-sectional analysis of pediatric RCTs registered on ClinicalTrials.gov between 2011 and 2013, with completion status by 2017. Inclusion criteria included clinical trials with drug interventions in participants aged 0-17 and randomization. Data on RCTs characteristics, including phase, funding source, participant age, and enrollment, were extracted. RCTs completion status was assessed, and reasons for incompletion were categorized. Publication status was evaluated through registry and manual searches on PubMed and Google Scholar. Statistical analyses, including logistic regression, were performed to identify factors associated with trial incompletion and non-publication.Results Out of 2875 pediatric clinical trials reviewed, 1088 met the inclusion criteria. Among these, 16.54% were uncompleted, primarily due to patient accrual issues (32.22%). Academic sponsors funded 48.53% of trials, and industrial sponsors funded 45.13%. Of 908 completed RCTs, 58.48% posted results in registries, while 70% had results published in peer-reviewed journals. Industrially funded RCTs were more likely to post results, but academic RCTs had a higher scientific publication rate. The median time to first result publication in registries was 21 months, with significant delays linked to the trial phase, funding, and participant enrolment size.Conclusion Our study highlights significant challenges in pediatric RCTs, including high incompletion rates and delays in result reporting. Ethical, regulatory, and logistical barriers hinder progress, impacting evidence transparency. Strengthened regulatory oversight and enhanced compliance are essential to improve pediatric research outcomes and ensure timely dissemination of RCTs results.
ER  -

NEBESKÁ, Kateřina; Lenka SOUČKOVÁ; Radka ŠTĚPÁNOVÁ a Regina DEMLOVÁ. Exploring the publication gap in pediatric randomized clinical trials: completed vs. uncompleted pediatric clinical trials. \textit{Frontiers in Medicine}. LAUSANNE: FRONTIERS MEDIA SA, 2025, roč.~12, May 2025, s.~1-13. ISSN~2296-858X. Dostupné z: https://doi.org/10.3389/fmed.2025.1590125.

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