Frameworks for Evaluating Medicines in Children

Turner, Mark A.; Hirschfeld, Steven

doi:10.1016/j.clinthera.2017.09.003

Cited by 7 publications

(1 citation statement)

References 38 publications

(36 reference statements)

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“…Repeated amendments and committee’s re-evaluations prolong ethics approvals and cause delays to the start of clinical trials, causing unnecessary loss of time and money. To avoid such pitfalls, consent and assent documents need to be designed according to high ethical standards 6 27–31…”

Section: Discussionmentioning

confidence: 99%

Informed consent and assent guide for paediatric clinical trials in Europe

et al. 2021

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ObjectiveClinical 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.MethodsCurrent 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.ResultsA 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%.ConclusionThe 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.

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Section: Discussionmentioning

confidence: 99%