Introduction
The EU Clinical Trials Regulation 2014 (CTRs) offers a great opportunity to improve research involving children. The supporting document "Ethical Considerations for Clinical Trials on Medicinal products conducted with Minors" is crucial to its implementation and achieving the Regulations’ aims to facilitate research and promote the health of our children and young people (minors).
This document represents the response from Enpr-EMA, its working groups (including representatives of networks, National Competent Authorities and pharmaceutical industry), and partners. It was led and drawn up by Hugh Davies (European Forum for Good Clinical Practice), Pirkko Lepola (Finnish Investigators Network for Pediatric Medicines, chair Enpr-EMA working group on Ethics) and Martine Dehlinger-Kremer (chair paediatric working group of EUCROF and member of EFGCP Children Working Party); then circulated to Enpr-EMA members and partners for their comments.
It is in two parts:
Part 1: General comments on guidance layout and content
Part 2: Specific comment on the text in the guidance with recommendations at the end of each
Executive summary
- This document must be written for all audiences, researchers, regulators, research ethic committees, but more importantly families and children.
- To improve readability, use of modern technology would allow the text to be layered providing easier reading and increasing detail.
- This guidance should
- be built around text from the regulations in each section
- offer advice on the interpretation of the regulations.
- seek and include evidence and practical examples wherever possible (we have tried to add some) .
- call for more research
- This guidance could profitably be built around “Principles underpinning ethical conduct of CTIMPS involving minors”.
- Children have vulnerabilities both as research participants and as recipients of unresearched care so fair balance must be struck between the two.
- Minors (children, young people and their families) should be involved in research from inception, in its design and the material to be used.
- Research involving minors must be preceded by careful risk assessment (benefits and harms) and then management.
- The arrangements for consent, assent and recognising dissent require specific consideration in clinical trials involving minors.
- Extrapolation of adult data is possible but this must be done with due care.
- Those conducting research involving minors should have appropriate expertise.
- Those reviewing research involving minors should have appropriate expertise.
- Openness and transparency are important parts of ethical research.
