For an alliance between science, ethics and politics in promoting paediatric trials. Commentary

Area of Science:

• Bioethics
• Pediatric Clinical Trials
• Regulatory Science

Background:

• Children were historically excluded from clinical research.
• Recent decades have seen a shift towards including pediatric populations in clinical trials.
• International and national provisions now encourage pediatric trial participation.

Purpose of the Study:

• To review the ethical considerations of including children in clinical trials.
• To provide concrete proposals for decision-makers regarding pediatric research.
• To inform the development of European Union regulations on pediatric clinical trials.

Main Methods:

• Review of existing literature and ethical guidelines.
• Analysis of international and national policies on pediatric trials.
• Consultation with stakeholders and experts.

Main Results:

• The Nuffield Council on Bioethics has published a comprehensive report on the topic.
• The report offers practical recommendations for ethical decision-making.
• The findings are timely given the ongoing development of EU regulations.

Conclusions:

• Inclusion of children in clinical trials is ethically imperative and legally supported.
• Clear guidelines and regulations are crucial for protecting pediatric participants.
• The Nuffield report provides a valuable framework for advancing pediatric research ethics.