RT Journal Article
SR Electronic
T1 Informed consent and assent guide for paediatric clinical trials in Europe
JF Archives of Disease in Childhood
JO Arch Dis Child
FD BMJ Publishing Group Ltd and Royal College of Paediatrics and Child Health
SP 582
OP 590
DO 10.1136/archdischild-2021-322798
VO 107
IS 6
A1 Pirkko Lepola
A1 Maxine Kindred
A1 Viviana Giannuzzi
A1 Heidi Glosli
A1 Martine Dehlinger-Kremer
A1 Harris Dalrymple
A1 David Neubauer
A1 Geraldine B Boylan
A1 Jean Conway
A1 Jo Dewhurst
A1 Diane Hoffman
YR 2022
UL http://adc.bmj.com/content/107/6/582.abstract
AB Objective Clinical trial sponsors spend considerable resources preparing informed consent (IC) and assent documentation for multinational paediatric clinical trial applications in Europe due to the limited and dispersed patient populations, the variation of national legal and ethical requirements, and the lack of detailed guidance. The aim of this study was to design new easy-to-use guide publicly available on European Medicines Agency’s, Enpr-EMA website for all stakeholders.Methods Current EU legal, ethical and regulatory guidance for paediatric clinical trials were collated, analysed and divided into 30 subject elements in two tables. The European Network of Young Person’s Advisory Group reviewed the data and provided specific comments. A three-level recommendation using ‘traffic light’ symbols was designed for four age groups of children, according to relevance and the requirements.Results A single guide document includes two tables: (1) general information and (2) trial-specific information. In the age group of 6–9 years old, 92% of the trial-specific subject elements can be or should be included in the IC discussion. Even in the youngest possible age group (2–5 years old children), the number of elements considered was, on average, 52%.Conclusion The EU Clinical Trial Regulation (2014) does not contain specific requirements exclusively for paediatric clinical trials. This work is the first to extensively collate all the current legal, regulatory and ethical documentation on the IC process, together with input from adolescents. This guide may increase the ethical standards in paediatric clinical trials.Data are available in a public, open access repository. All data are publicly available via Enpr-EMA website: https://www.ema.europa.eu/en/documents/other/assent/informed-consent-guidance-paediatric-clinical-trials-medicinal-products-europe_en.pdf.