Trial reportEuropean journal of clinical pharmacology2011
Ethical key issues and fundamental rights in paediatric research.
Trial report in European journal of clinical pharmacology, 2011. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 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
3 citing papers in PubMed.
- Engaging children, adolescents and young adults living with rare diseases as research partners: practical considerations for meaningful involvement.Frontiers in pediatrics · 2026Article
- Article
- Ethics review of pediatric multi-center drug trials.Paediatric drugs · 2015Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
1 author.
Funding
No grant is acknowledged in the PubMed record.
Abstract
purposeThis article is aimed at describing the methodology of "ethical reasoning" that finally led TEDDYNoE (Task-force in Europe for Drug Development for the Young) to propose the integration of international human rights law to develop coherent and exhaustive ethical recommendations on paediatric research at a European level.
methodsA large number of ethical guidelines and texts of varying legal force existing in the field of clinical research and in particular related to paediatrics are analysed. Differences and non-coordinated implementation are pointed out.
resultsDifferences, tensions or outright contradictions among the provisions of these texts can generate confusion leading to the adoption of different ethical standards across Europe. In this context, the real challenge is to ensure that each child involved in a clinical trial in the EU territory may rely directly on the same principles and rights. Taking international human rights law as the main starting point to develop a coherent framework for paediatric research that incorporates all the relevant ethical considerations and existing guidelines is a way of achieving this objective.
conclusionsThe implementation, at national and local level, of the "European Ethical Recommendations" (Eudralex 2008 vol. 10), based on international human rights law, seems to be the next step in facilitating a coordinated approach to the application of the Directive 2001/20/EC, as well as developing quality and ethically sound paediatric research.
Indexed as
Identifiers
21103986What 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.