SynthesisJournal of paediatrics and child health2026
Placebo in Paediatric Clinical Trials: Systematic Literature Review and Framework-Based Synthesis.
Synthesis in Journal of paediatrics and child health, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
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
0 citing papers in PubMed.
No citing paper in PubMed yet.
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
6 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
introductionPlacebo-controlled trials can provide strong evidence on safety and efficacy, but their ethical acceptability in paediatric research is contested because children have limited decisional capacity and placebo use may entail withholding effective therapy.
objectiveTo identify the ethical and methodological conditions under which placebo controls are acceptable in paediatric clinical trials, using a systematic review of the literature and regulatory guidance.
methodsWe searched Medline, Scopus and Embase for sources addressing the ethics, acceptability or regulation of placebo use in paediatric trials. We extracted study characteristics and ethical arguments, mapped them to beneficence, non-maleficence, autonomy and justice, and then synthesised findings using Emanuel, Wendler and Grady's seven requirements for ethical clinical research. We also obtained expert guidance from UK, USA and European regulators.
resultsWe included 51 sources spanning neonatal research, disease-specific paediatric contexts, parental perspectives and general ethics/regulatory discussions. Placebo was generally considered acceptable when methodologically necessary and scientifically sound, when no proven effective therapy was withheld (or any withholding carried minimal incremental risk), and when safeguards such as rescue therapy, early escape, and close monitoring were in place. Common emphases included limits on non-beneficial risk in children, assent and parental permission, and fair participant selection.
conclusionPlacebo use in paediatric trials is acceptable only under constrained conditions centred on scientific necessity, minimising harm from withholding therapy, robust safeguards and appropriate permission/assent processes. Further work should translate these conditions into disease-specific, operational guidance.
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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.