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COVID-19, children, clinical trials and compassion: The ethical case for using innovative or compassionate treatments
Vic Larcher1, Art Caplan2, Joe Brierley1
1Paediatric Bioethics Centre, University College London, Great Ormond Street Institute of Child Health, NIHR Great Ormond Street Hospital Biomedical Research Centre, London, UK.
Insights
Children should have early access to innovative treatments for severe acute respiratory syndrome-coronavirus-2 (SARS-CoV-2) during pandemics. Paediatric-specific research is crucial to establish safe and effective treatment pathways for pediatric COVID-19 patients.
Area of Science:
- Pediatric Infectious Diseases
- Clinical Pharmacology
- Public Health Policy
Background:
- Determining safe and effective treatments for SARS-CoV-2 remains a challenge.
- Children with COVID-19 are considered therapeutic orphans, lacking specific treatment guidelines.
- Emergence of pediatric inflammatory multisystem syndrome temporally associated with SARS-CoV-2 (MIS-C) highlights the need for pediatric-specific research.
Purpose of the Study:
- To advocate for children's right to access innovative treatments during pandemics.
- To address the ethical considerations of providing early access to novel therapies for pediatric COVID-19.
- To emphasize the necessity of dedicated pediatric clinical trials for COVID-19 treatment.
Main Methods:
- Review of current treatment strategies and ethical considerations for pediatric COVID-19.
- Analysis of the limitations of including children in adult-focused clinical trials.
- Discussion of the urgency for developing child-specific treatment protocols.
Main Results:
- Current evidence does not support withholding treatments effective in adults from children.
- Dedicated, appropriately powered pediatric trials are needed to establish specific child-COVID-19 treatment pathways.
- The time frame for generating child-specific data raises concerns about timely access to care.
Conclusions:
- Children should have the right to access innovative pandemic treatments early, based on individual best interests.
- This access should continue until formal, powered studies determine optimal pediatric treatment.
- Data from early innovative use should be made available to researchers to inform future studies.
Aim:
Safe, effective SARS-CoV-2 treatment has not yet been determined, though some drugs have favourable mortality and morbidity benefits in specific situations. No treatments have been explicitly tested in children, who are, therefore, once again therapeutic orphans.
Method:
We echo calls to enrol patients, including children, into trials but those children recruited to date have largely been additions to adult studies. Few were recruited during the initial pandemic despite the emergence of PIMS-TS/MIS-C, which surely demands paediatric-specific research.
Result:
Must children be proscribed treatments effective in adults until child-specific data emerges, even in a pandemic? Will appropriately powered dedicated trials ever determine specific child-COVID-19 treatment pathways? Is the protracted time frame to assemble such data acceptable to children with severe COVID-19 today? Such factors are relevant in considering whether children should have access to compassionate, innovative, pandemic-disease treatment.
Conclusion:
We argue that children should be permitted, indeed have a right, to access innovative treatments early in any future pandemic, following an individual best interests consideration. This will remain the case until formal studies powered to determine children's optimal treatment commence, when the moral duty switches to ensuring children are enrolled, with any preceding innovative-use data made available to researchers.
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