ReviewBritish journal of clinical pharmacology2019
Paediatric extrapolation: A necessary paradigm shift.
Review in British journal of clinical pharmacology, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 18 papers, 1 of them a synthesis that pooled it.
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
18 citing papers in PubMed, 1 synthesis or guideline pooled it.
- Pooled it
- Population Pharmacokinetic Modeling and Probability of Pharmacodynamic Target Attainment for Ceftazidime-Avibactam in Pediatric Patients Aged 3 Months and Older.Clinical pharmacology and therapeutics · 2022Trial
- Health Technology Assessment Guidelines and Recommendations Across European Union Countries and the United Kingdom in Rare Disease and Paediatric Populations.Applied health economics and health policy · 2026Article
- Application of a Stochastic Simulation-estimation Approach to Optimize Pharmacokinetic Study Design in the Context of Paediatric Extrapolation: A Tool to Support Decision-making by Drug Sponsors and Regulators.Pharmaceutical research · 2026Article
- Insights into the adoption of innovative clinical trials across therapeutic areas using clinical trials registry data and large Language models.Scientific reports · 2025Article
- Ag(e)nostic precision oncology therapy approvals across the years.Trends in cancer · 2025Review
- Did pediatric drug development advance epilepsy treatment in young patients? It is time for new research goals.World journal of methodology · 2024Review
- Pediatric Market Access: A Qualitative Study.Therapeutic innovation & regulatory science · 2024Article
- Current knowledge, challenges and innovations in developmental pharmacology: A combined conect4children Expert Group and European Society for Developmental, Perinatal and Paediatric Pharmacology White Paper.British journal of clinical pharmacology · 2022Review
- Extrapolation as a Default Strategy in Pediatric Drug Development.Therapeutic innovation & regulatory science · 2022Article
- Ensuring continued progress for development of COVID-19 therapeutics in children.Pediatric research · 2021Article
- COVID-19 and Treatment and Immunization of Children-The Time to Redefine Pediatric Age Groups is Here.Rambam Maimonides medical journal · 2021Review
- Developmental Pharmacodynamics and Modeling in Pediatric Drug Development.Journal of clinical pharmacology · 2019Review
- New Strategies for the Conduct of Clinical Trials in Pediatric Pulmonary Arterial Hypertension: Outcome of a Multistakeholder Meeting With Patients, Academia, Industry, and Regulators, Held at the European Medicines Agency on Monday, June 12, 2017.Journal of the American Heart Association · 2019Article
- Paediatric extrapolation: the panacea for paediatric drug development?British journal of clinical pharmacology · 2019Article
- Paediatric extrapolation: A necessary paradigm shift.British journal of clinical pharmacology · 2019Review
- Commentary on the EMA Reflection Paper on the use of extrapolation in the development of medicines for paediatrics.British journal of clinical pharmacology · 2019Article
- Implications of Pediatric Initiatives on CNS Drug Development for All Ages-2020 and Beyond: Second of Three Sets of Expanded Proceedings from the 2020 ISCTM Autumn Conference on Pediatric Drug Development.Innovations in clinical neuroscienceArticle
Corrections and comments
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Authors and funding
5 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Legislative initiatives have been successful in increasing the availability of approved therapies for paediatric patients. However, additional measures to ensure the timely completion of paediatric studies are necessary to further increase the number of medicines available to children. Over the last 3 years, international experts convened to revise the ICH E11 guideline on clinical investigations of medicinal products in paediatric populations to harmonize approaches to paediatric extrapolation, striving to reduce substantial differences between regions in the acceptance of data for global paediatric medicine development programmes. Several areas of therapeutics development in children, such as human immunodeficiency virus and partial-onset seizures, have been streamlined and require fewer children enrolled in clinical trials because of the appropriate application of paediatric extrapolation. Based on this experience, it is clear that for paediatric extrapolation strategies to reach their full potential there is the need to understand the quality and quantity of data, often collected in adult patients, that will inform the appropriateness of the use of paediatric extrapolation, as well as to identify gaps in knowledge with respect to disease pathophysiology, organ maturation or drug target ontogeny. The generation of information that enhances our current understanding of these gaps in knowledge can further decrease the need for larger, paediatric clinical trials and can increase the efficiency of paediatric therapeutics development as well as protect children from participation in unnecessary studies. We hope that this publication will increase awareness, input and support from all the stakeholders involved in paediatric therapeutics development.
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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.