ArticleEuropean journal of cancer (Oxford, England : 1990)2019
Timing of first-in-child trials of FDA-approved oncology drugs.
Article in European journal of cancer (Oxford, England : 1990), 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 38 papers.
What it found
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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.
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Who cites it
38 citing papers in PubMed.
- Matched Targeted Therapy for Pediatric Patients with Relapsed, Refractory, or High-Risk Leukemias: A Report from the LEAP Consortium.Cancer discovery · 2021Trial
- Paediatric Phase I/II Clinical Trial Assessments Under the New EU Clinical Trial Regulation: A Descriptive Analysis.Pharmaceutical medicine · 2026Article
- Advancing precision therapy in pediatric acute myeloid leukemia through PDX models and mitochondrial targeting.Blood advances · 2026Article
- Global regulatory variability in small-molecule inhibitor approvals: Differences in timelines, dosing, and pediatric indications across FDA, EMA, and PMDA.Clinical & translational oncology : official publication of the Federation of Spanish Oncology Societies and of the National Cancer Institute of Mexico · 2026Article
- New Quinoline Kinase Inhibitors With Good Selectivity for NAK Kinases and Anti-Tumor Activity Against Ewing Sarcoma.Archiv der Pharmazie · 2026Article
- Three-Dimensionally Printed Paediatric Medicines: Formulation, Process, and Regulatory Considerations.Pharmaceutics · 2025Review
- Review
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- Incorporation of patient-reported outcomes in pediatric cancer clinical trials: design, implementation, and dissemination.Journal of the National Cancer Institute · 2025Article
- Dosage Optimization of Pediatric Oncology Products: Our Patients Deserve Better.Clinical cancer research : an official journal of the American Association for Cancer Research · 2025Review
- Vincristine Sulfate Liposome Injection With Combination Chemotherapy for Children, Adolescents, and Young Adults With Relapsed Acute Lymphoblastic Leukemia: A Therapeutic Advances in Childhood Leukemia and Lymphoma Consortium Trial.Pediatric blood & cancer · 2025Article
- Scientific and regulatory progress in advancing paediatric oncology drug development in the EU and in the US.Frontiers in medicine · 2025Article
- Pediatric Cancer Drug Development: Leveraging Insights in Cancer Biology and the Evolving Regulatory Landscape to Address Challenges and Guide Further Progress.Cold Spring Harbor perspectives in medicine · 2024Review
- Impact of ACCELERATE Paediatric Strategy Forums: a review of the value of multi-stakeholder meetings in oncology drug development.Journal of the National Cancer Institute · 2024Review
- Access to innovative therapies in pediatric oncology: Report of the nationwide experience in Canada.Cancer medicine · 2024Article
- Ensuring access to innovative therapies for children, adolescents, and young adults across Canada: The single patient study experience.Paediatrics & child health · 2023Review
- Children's Oncology Group's 2023 blueprint for research.Pediatric blood & cancer · 2023Article
- Clinical development of new drugs for adults and children with cancer, 2010-2020.Journal of the National Cancer Institute · 2023Article
- Combination Early-Phase Trials of Anticancer Agents in Children and Adolescents.Journal of clinical oncology : official journal of the American Society of Clinical Oncology · 2023Review
- The Development of New Agents for Post-Hematopoietic Stem Cell Transplantation Non-Infectious Complications in Children.Journal of clinical medicine · 2023Review
Corrections and comments
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Authors and funding
3 authors.
Funding
Abstract
aimThe lag time between initial human studies of oncology agents and the first-in-child clinical trials of these agents has not been defined.
methodsWe conducted a systematic analysis of time from first-in-human trials to first-in-child trials (age of eligibility <18 years) of agents first approved by the US Food and Drug Administration (FDA) for any oncology indication from 1997 to 2017. We used clinical trial registry data, published literature and oncology abstracts to identify relevant trials and start dates.
resultsFrom 1997 to 2017, 126 drugs received initial FDA approval for an oncology indication. Of these, 117 were non-hormonal agents used in subsequent analyses. Fifteen of 117 drugs (12.8%) did not yet have a paediatric trial, and six of 117 drugs (5.1%) had an initial approval that included children. The median time between the first-in-human trial and first-in-child trial was 6.5 years (range 0-27.7 years). The median time from initial FDA approval to the first-in-child clinical trial was -0.66 years (range -43 to +19 years). These values were stable regardless of year of initial FDA approval, drug class and initial approved disease indication.
conclusionThe median lag time from first-in-human to first-in-child trials of oncology agents that were ultimately approved by FDA was 6.5 years. These results provide a benchmark against which to evaluate recent initiatives designed to hasten drug development relevant to children with cancer.
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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.