key: cord-0743190-1uprz0lu
authors: Meena, Jitendra; Yadav, Arushi; Kumar, Jogender
title: Ostracizing Children from Research in COVID-19: Is it Ethical?
date: 2020-10-08
journal: Indian J Pediatr
DOI: 10.1007/s12098-020-03525-3
sha: 46c3e5e6af35122437ad79e35aaa80714849ce63
doc_id: 743190
cord_uid: 1uprz0lu

nan

Despite the evidence, its use in children is limited by a lack of proven efficacy data in them. Hydroxychloroquine, which has been used off-label in children for many years in the treatment of autoimmune disorders and is studied in the non-COVID-19 clinical trial too, has shown the same exclusion in COVID-19 trial [6] . Many COVID-19 trials evaluating drugs that are widely used in pediatrics for other clinical indications also excluded children (Supplementary Table 1 ). The zeal for developing vaccines against SARS-CoV-2 appears paradoxical by leaving behind the vulnerable population and violates the action rule of equitable access to an intervention for a new disease.

Including children in clinical trials for newer intervention might result in better understanding of pharmacokinetics and dynamics (e.g., rapid metabolism of cyclosporin), immune response (like vaccines), unexpected responses (e.g., Grey baby syndrome in chloramphenicol), adverse drug reactions (e.g., gasping syndrome from benzyl alcohol) which might be different from the adults and can have a potential bearing over their growth (as seen with tetracycline), development, and future reproductive potential (cytotoxic therapy). If we do not recruit the children in clinical trials for COVID-19 therapy, we might end-up extrapolating data from adults and subjecting a large number of children to unknown risks, that too without monitoring.

To ensure equitable standards, regulatory bodies must ensure adequate participation of children in clinical trials [5] . Their vulnerability can be mitigated by adhering to the country-specific ethics guidelines. They should be only included in the trials that will have a direct benefit to them (holds for COVID). The research should be preferably done in the least vulnerable age-group with explicit informed consent from the parents and assent from the child. The consent and assent should clearly explain the therapy under investigation including its result in adults, potential danger to the child (including the painful procedures, amount of blood to be taken, etc), and measures in place to mitigate these risks. Involving the patient's representative bodies and pediatricians in the design of the trial and data safety monitoring bodies shall help protect the child's interests [5] .

Pathophysiology, transmission, diagnosis, and treatment of coronavirus disease 2019 (COVID-19): a review

COVID-19 in different age groups of children: initial impression from integrated disease surveillance programme (IDSP) under National Centre for Disease Control (NCDC)

Dexamethasone in hospitalized patients with Covid-19 -preliminary report

Remdesivir for the treatment of Covid-19 -preliminary report

Vulnerable population and methods for their safeguard

Randomized trial of hydroxychloroquine for newly diagnosed chronic graft-versus-host disease in children: a Children's oncology group study

Publisher's Note Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations

The autonomy of children is vested in us (pediatricians), therefore ensuring justice to them by inclusion in the clinical research intended for their benefit is our responsibility.

Conflict of Interest None.