Paediatric Research Consultancy

  Helps optimise paediatric trial planning to improve recruitment and compliance

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  • Paediatric information sheets

        Paediatric Research Consultancy™  can provide age-appropriate child-friendly information. This mother and chlld clearly enjoy reading together - but a more child-friendly version would be better.

    PRC's Jane Lamprill  is a trained and published children's author as well as having 17 years paediatric trials experience. Since 1999 she has been writing copy for paediatric information sheets, child healthcare communications and consent/assent forms which have been translated for paediatric studies all over the world.

    European Clinical Trials Direcive 2001/20/EC states in Article 4 that: "a clincial trial on minors may only be undertaken if ... the minor has received information according to its capacity of understanding...." Any parent/child information  that is a lengthy and  full of scientific complexities  is a waste of company time and money and is in breach of this law. It will result in un-informed consent, zero/poor trial recruitment – and is often used to make paper aeroplanes!

    Paediatric clinical trial information sheets that are age-appropriate and meet the study needs of the child and family result in better recruitment and compliance as long as the protocol itself is workable for a paediatric population. 

    Children: Clinical trial information should be easy to read and factual without being frightening. The European research guidance ICH E11 Reference 8 states that “All participants should be informed to the fullest extent possible…in language and terms they are able to understand”. This is now a legal requirement in the UK References 9,10.

    Pharmaceutical companies and medical researchers testing paediatric medicines are therefore required to write information for children at a level appropriate for the reading age/ability of the population to be tested. It is very important that the information makes it clear that taking part is completely voluntary and nobody will be angry with the child if they don’t want to take part. They can say “no” at any time before or during the research without having to give a reason.

    Various formats are appropriate for different ages - comic strip material is great for boys and teenagers but suggest careful user testing  as the use of cartoons may cause some children to confuse fact with fantasty. Artwork is required in the UK for young children who cannot read. Make sure the pictures DO NOT show needles!

    Parents: are extremely protective of their children. Information needs to be non technical, factual and concise without being patronising or frightening.

    If you require assistance with your child/parent information sheets, consent or assent forms, please click here

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