ArticleEuropean journal of health law2008
European Union. Ethical considerations for clinical trials on medicinal products conducted with the paediatric population.
Article in European journal of health law, 2008. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT06012266 (Dose Rationale for Dapagliflozin and Empagliflozin in Paediatric Heart Failure), which is not on this map. Cited by 49 papers, 5 of them syntheses 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.
Dose Rationale for Dapagliflozin and Empagliflozin in Paediatric Heart Failure: a Phase II.a Pharmacokinetics, Ease-of-swallow, Safety and Proof-of-concept Study Among Children 6-18 Years of Age
Who cites it
49 citing papers in PubMed, 5 syntheses or guidelines pooled it.
- An Umbrella Review of Systematic Reviews of School-Based Nutrition Interventions to Determine Outcomes Used and Their Measurement Tools.Nutrition reviews · 2026Pooled it
- Vulnerability in research ethics: A systematic review of policy guidelines and documents.PloS one · 2025Pooled it
- Central nervous system germ cell tumor, an archetypal AYA tumor and a model for pediatric and neuro-oncology collaboration, review from the EURACAN domain 10 group.Frontiers in oncology · 2022Pooled it
- Systematic review: bioethical implications for COVID-19 research in low prevalence countries, a distinctly different set of problems.BMC medical ethics · 2021Pooled it
- Intermittent versus daily therapy for treating tuberculosis in children.The Cochrane database of systematic reviews · 2014Pooled it
- Can non-pharmacological comfort care replace fentanyl in LISA? The NONA-LISA feasibility study.Pediatric research · 2026Trial
- Population Pharmacokinetic Analysis of Enalapril and Enalaprilat in Newly Treated Children with Heart Failure: Implications for Safe Dosing of Enalapril (LENA Studies).Clinical pharmacokinetics · 2025Trial
- Trial
- Methoxyflurane Analgesia in Adult Patients in the Emergency Department: A Subgroup Analysis of a Randomized, Double-blind, Placebo-controlled Study (STOP!).Advances in therapy · 2016Trial
- Clinical Research in Vulnerable Populations: Variability and Focus of Institutional Review Boards' Responses.PloS one · 2015Trial
- Efficacy of pneumococcal nontypable Haemophilus influenzae protein D conjugate vaccine (PHiD-CV) in young Latin American children: A double-blind randomized controlled trial.PLoS medicine · 2014Trial
- Effect of topical anaesthetics on interstitial colloid osmotic pressure in human subcutaneous tissue sampled by wick technique.PloS one · 2012Trial
- Repurposing Empagliflozin for Duchenne Muscular Dystrophy-Associated Cardiomyopathy: Protocol for a Pharmacokinetics, Safety and Proof-of-Concept Trial in Children.Cardiology and therapy · 2026Article
- T-cell Response Induced by the BNT162b2 COVID-19 Vaccine in Children.Open forum infectious diseases · 2025Article
- Decentralized Clinical Trials in Pediatrics: Is Italy Ready?Journal of clinical medicine · 2025Article
- Ethical Biobanking in Extremely Preterm Infants: Lessons From the EPITOP Study.Acta paediatrica (Oslo, Norway : 1992) · 2025Article
- Mapping the rare disease paediatric clinical trial availabilities in Europe.Frontiers in pediatrics · 2025Article
- Empagliflozin in paediatric heart failure: model-based optimisation of a pharmacokinetic bridging study.Frontiers in medicine · 2025Article
- Article
- Systemic treatment of recessive dystrophic epidermolysis bullosa with mesenchymal stromal cells: a scoping review of the literature and conclusions for future clinical research.The Journal of dermatological treatment · 2024Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
0 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
This document has been developed by the ad hoc group for the development of implementing guidelines for Directive 2001/20/EC relating to good clinical practice in the conduct of clinical trials on medicinal products for human use, chaired by the European Commission. The document provides recommendations on various ethical aspects of clinical trials performed in children from birth up to the legal age of adulthood. This will contribute to the protection of all children who are the subject of clinical trials. As the approval of clinical trials, including ethical approval, is performed by the Member States, any recommendations on ethical aspects of clinical trials in children will also facilitate a harmonised approach to the application of the clinical trials directive across the EU, thereby facilitating the conduct of clinical trials in the EU and in whichever country the paediatric trial occurs. The protection against the risks of research in such a vulnerable population is paramount whilst this should not lead to denying them the benefits of research. Children are not small adults and there is a need to carry out specific trials that cannot be performed in adults. In general, children (minors) are unable to consent (in the legal sense) but their assent should be sought using age appropriate information. Ethics Committees need paediatric expertise to balance the benefits and risks of research in children. The lack of legal ability to consent has implications on the design, analysis and the choice of comparators used in trials, which should only be performed by trained investigators with paediatric experience. Pain, fear, distress and parental separation should be prevented and minimised when unavoidable. The neonate represents the most vulnerable of all paediatric age groups and requires even more careful review. Finally, various other aspects relating to the performance of trials in children are discussed.
Indexed as
Identifiers
18988606What 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.