ArticleClinical pharmacology and therapeutics2020
Combined Pediatric and Adult Trials Submitted to the US Food and Drug Administration 2012-2018.
Article in Clinical pharmacology and therapeutics, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 17 papers.
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
17 citing papers in PubMed.
- Achievement of therapeutic antibiotic exposures using Bayesian dosing software in critically unwell children and adults with sepsis.Intensive care medicine · 2024Trial
- Characteristics of Dupilumab-Treated Patients with Atopic Dermatitis Over Time: A Cross-Sectional Assessment of Potential Channeling Bias upon Pediatric Label Extension.Dermatology and therapy · 2026Article
- Pharmacokinetics of Monoclonal Antibodies in Pediatrics: Model-Based Investigation on Allometric Scaling Exponents.Pharmaceutics · 2026Article
- How can innovative trials in juvenile idiopathic arthritis serve the unmet needs of patients?Arthritis research & therapy · 2026Review
- Effect of Incentivizing Pediatric Studies on the Development of Pediatric-Friendly Formulations.The AAPS journal · 2026Article
- Review
- Ag(e)nostic precision oncology therapy approvals across the years.Trends in cancer · 2025Review
- The Challenges of New Biologic Therapies in Pediatrics: An Update on the Limited Therapeutic Options for Juvenile Psoriatic Arthritis.Rheumatic diseases clinics of North America · 2025Review
- Paediatric Drug Development in Japan: Current Status and Future Challenges.Therapeutic innovation & regulatory science · 2025Article
- Assessment of Dosing Strategies for Pediatric Drug Products.Clinical pharmacology and therapeutics · 2024Review
- Pediatric Drug Development: Reviewing Challenges and Opportunities by Tracking Innovative Therapies.Pharmaceutics · 2023Review
- I-ACT for Children: helping close the gap in drug approval for adults and children.Pediatric research · 2023Article
- Elbasvir/grazoprevir in children aged 3-18 years with chronic HCV genotype 1 or 4 infection: a pharmacokinetic modeling study.Hepatology communications · 2023Article
- Accelerating the Availability of Medications to Pediatric Patients by Optimizing the Use of Extrapolation of Efficacy.Therapeutic innovation & regulatory science · 2022Review
- Regarding Combined Pediatric and Adult Trials Submitted to the US Food and Drug Administration 2012-2018.Clinical pharmacology and therapeutics · 2021Article
- The Revolution in Pediatric Drug Development and Drug Use: Therapeutic Orphans No More.The journal of pediatric pharmacology and therapeutics : JPPT : the official journal of PPAG · 2020Article
- Pre-Clinical and Clinical Therapies for Traumatic Brain Injury: Where Do We Stand in Pediatrics?Neurotrauma reportsReview
Corrections and comments
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Authors and funding
10 authors.
Funding
Abstract
Despite legislation incentivizing and requiring drug companies to conduct pediatric clinical trials, there still is a 9-year delay in drug approval for pediatric labeling after the initial adult drug approval. The aim of this study was to review the experience of the US Food and Drug Administration (FDA) with combined pediatric and adult trials as a means for expediting pediatric approval and labeling. Combined pediatric and adult trials submitted to the FDA from 2012 to 2018 were reviewed. Only the publicly available labels and reviews were utilized for this analysis. Combined trials were identified for 72 products, with a total of 156 combined adult and pediatric trials. The therapeutic areas with the largest number of combined trials were in pulmonology for products reviewed under the Best Pharmaceuticals for Children Act (BPCA) and/or the Pediatric Research Equity Act (PREA), and hematology reviewed under the Orphan Drug Act (ODA). All drugs that utilized combined pediatric and adult clinical trials were approved simultaneously for both the adults and that part of the pediatric population. A separate pediatric subgroup efficacy analysis was reported in 57% and 48% of products under BPCA/PREA and the ODA, respectively, with a separate safety analysis in 48% and 38% of these products. When considering both BPCA/PREA and orphan drug studies, all the combined pediatric and adult trials allowed concurrent approval and labeling for part of the pediatric population at the time of the adult approval.
Indexed as
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What OpenQuestion holds
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.