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Importance of Pediatric Inclusion in COVID-19 Therapeutic Trials

Vanessa N Raabe1,2, Jennifer Lighter1, Arthur L Caplan3

  • 1Department of Pediatrics, Division of Pediatric Infectious Diseases, New York University Grossman School of Medicine, New York, New York, USA.

Clinical Infectious Diseases : an Official Publication of the Infectious Diseases Society of America
|May 28, 2020
PubMed

Insights

Most coronavirus disease 2019 (COVID-19) drug trials exclude children. This study provides a rationale for including pediatric patients in COVID-19 therapeutic trials, allowing all ages to participate in research.

Area of Science:

  • Pediatric infectious diseases
  • Clinical trial design
  • Epidemiology

Background:

  • Most coronavirus disease 2019 (COVID-19) therapeutic trials have excluded pediatric populations.
  • This exclusion limits understanding of disease progression and treatment efficacy in children.
  • Lack of pediatric data hinders the development of age-specific treatment guidelines.

Purpose of the Study:

  • To present a rationale for the inclusion of pediatric patients in coronavirus disease 2019 (COVID-19) therapeutic trials.
  • To advocate for the enrollment of children of all ages in clinical research for COVID-19 therapeutics.
  • To address the gap in evidence regarding the safety and effectiveness of COVID-19 treatments in pediatric populations.

Main Methods:

  • Review of existing literature on pediatric exclusion criteria in clinical trials.
  • Development of a justification based on ethical considerations and scientific necessity.
  • Proposal for modifications to trial protocols to accommodate pediatric participants.

Main Results:

  • A clear rationale was established for including all pediatric age groups in COVID-19 therapeutic trials.
  • The proposed approach facilitated the inclusion of children in a specific institutional trial.
  • This inclusive strategy expands the generalizability of research findings to the entire population.

Conclusions:

  • Including pediatric patients in coronavirus disease 2019 (COVID-19) therapeutic trials is essential for comprehensive research.
  • A strong rationale supports the inclusion of children, enabling broader participation in clinical studies.
  • This approach ensures that evidence-based treatments are available for all age groups affected by COVID-19.

Keywords:
COVID-19SARS-CoV-2clinical trialethicspediatrics

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