ArticleArchives of disease in childhood2022
Informed consent and assent guide for paediatric clinical trials in Europe.
Article in Archives of disease in childhood, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 16 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
16 citing papers in PubMed, 1 synthesis or guideline pooled it, 25 citations in OpenAlex.
- Placebo in Paediatric Clinical Trials: Systematic Literature Review and Framework-Based Synthesis.Journal of paediatrics and child health · 2026Pooled it
- Children's participation in assent to paediatric oncology research: experiences of children, siblings and parents.Trials · 2026Article
- Why children's research assent matters: Exploring three dimensions of autonomy.Nursing ethics · 2026Article
- Navigating ethical challenges in the FORTEe randomised controlled trial: a multi-centre staff survey on exercise intervention for children and adolescents undergoing cancer treatment.BMC medical ethics · 2026Article
- HIV Cure Research: Ethical and Real-World Practical Considerations for Pediatric and Adolescent Populations.Journal of the Pediatric Infectious Diseases Society · 2026Article
- Developing a Parent-Focused Decision Aid to Promote Child-Inclusive Shared Decision-Making in Pediatric Oral Immunotherapy: Pragmatic Exploratory Feasibility Study.Journal of participatory medicine · 2026Article
- Research on issues in the protection of clinical trial human subjects in China: a Delphi study.BMC medical ethics · 2025Article
- Decentralized Clinical Trials: Governance, Ethics and Medico-Legal Issues for the New Paradigm of Research with a Focus on Cardiovascular Field.Medical sciences (Basel, Switzerland) · 2025Review
- Ethical and regulatory requirements for conducting researcher-driven large-scale multinational genetic haematological studies: the INHERENT experience.Health research policy and systems · 2025Article
- Analysis of pediatric assent information in early-phase cancer clinical trials through a children's research advisory group.Frontiers in psychology · 2025Article
- Requirements and special considerations for drug trials with children across six jurisdictions: 2. Ethics review in the regulatory approval process.Frontiers in medicine · 2025Article
- Including the voice of children <15-years-old in paediatric global health research.Current tropical medicine reports · 2024Article
- The oral microbiome of children in health and disease-a literature review.Frontiers in oral health · 2024Review
- Balancing ethical norms and duties for the introduction of new medicines through conditional marketing authorization: a research agenda.Frontiers in medicine · 2024Article
- PedCRIN tool for the biosamples management in pediatric clinical trials.Clinical and translational science · 2023Article
- What information and the extent of information to be provided in an informed assent/consent form of pediatric drug trials.BMC medical ethics · 2022Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
11 authors at 8 institutions in 7 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
objectiveClinical trial sponsors spend considerable resources preparing informed consent (IC) and assent documentation for multinational paediatric clinical trial applications in Europe due to the limited and dispersed patient populations, the variation of national legal and ethical requirements, and the lack of detailed guidance. The aim of this study was to design new easy-to-use guide publicly available on European Medicines Agency's, Enpr-EMA website for all stakeholders.
methodsCurrent EU legal, ethical and regulatory guidance for paediatric clinical trials were collated, analysed and divided into 30 subject elements in two tables. The European Network of Young Person's Advisory Group reviewed the data and provided specific comments. A three-level recommendation using 'traffic light' symbols was designed for four age groups of children, according to relevance and the requirements.
resultsA single guide document includes two tables: (1) general information and (2) trial-specific information. In the age group of 6-9 years old, 92% of the trial-specific subject elements can be or should be included in the IC discussion. Even in the youngest possible age group (2-5 years old children), the number of elements considered was, on average, 52%.
conclusionThe EU Clinical Trial Regulation (2014) does not contain specific requirements exclusively for paediatric clinical trials. This work is the first to extensively collate all the current legal, regulatory and ethical documentation on the IC process, together with input from adolescents. This guide may increase the ethical standards in paediatric clinical trials.
Indexed as
Identifiers
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.