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.
Abstract

Related Concept Videos

Ethical Issues01:27

Ethical Issues

Nurses are essential in patient care, upholding the ethical principles of their profession and effectively navigating ethical dilemmas. Neglecting ethical issues can lead to inadequate patient care, compromised therapeutic relationships, and moral distress among healthcare workers.
Ethical Concerns in Healthcare:
1.4K
Ethical Dilemmas I01:17

Ethical Dilemmas I

Ethical dilemmas in nursing are of utmost importance, as they often arise from the tension between adhering to core ethical principles and the practical realities of healthcare delivery. These dilemmas require nurses to navigate complex situations where competing ethical considerations pull them in different directions.
Let us explore some examples to understand the potentially complex moral decisions nurses face.
Take the case of caring for minors, particularly in areas related to reproductive...
1.2K
Nursing Ethical Principles II01:27

Nursing Ethical Principles II

Ethical principles are essential in guiding nurses to fulfill their responsibilities, focusing on the quality of nursing care and decision-making. These principles, including autonomy, beneficence, non-maleficence, justice, and fidelity, shape the ethical framework within healthcare settings.
Consider the following scenario, which illustrates how these principles are applied in the care of Mr. John, a fifty-year-old teacher diagnosed with metastatic liver cancer.
Initially, Mr. John's...
1.5K
Clinical Trials: Overview01:11

Clinical Trials: Overview

Clinical development focuses on how the drug will interact with the human body and encompasses four key phases of clinical trials, each serving a specific purpose in assessing the safety and effectiveness of new drugs. These phases overlap and build upon one another. Phase I involves a small group of healthy volunteers (typically 20-80 individuals) or, in cases where significant toxicity is expected, patients with the targeted disease, such as cancer or AIDS. The volunteers are tested for...
3.9K
Clinical Trials01:16

Clinical Trials

Clinical trials are prospective experimental studies conducted on humans to determine the safety and efficacy of treatments, drugs, diet methods, and medical devices. Using statistics in clinical trials enables researchers to derive reasonable and accurate conclusions from the collected data, allowing them to make wise decisions in uncertain situations. In medical research, statistical methods are crucial for preventing errors and bias.
There are four phases in a clinical trial. A phase one...
9.7K
Ethics in Research01:56

Ethics in Research

Today, scientists agree that good research is ethical in nature and is guided by a basic respect for human dignity and safety. However, this has not always been the case. Modern researchers must demonstrate that the research they perform is ethically sound.
24.8K