Paediatric Research CommunicationsTM
Welcome! Paediatric Research CommunicationsTM started as Paediatric Research ConsultancyTM and is now part of Please Read Carefully.TM
Jane Lamprill is a specialist health writer for children of all ages and cognitive abilities. She has many years’ experience working with children and families, in healthcare and clinical research settings.
Jane can work with you to improve recruitment and compliance, by writing clear, child-focussed health and research materials.
Paediatric medicines research - the information gap
Pharmaceutical companies are now required to make medicines especially designed for children .(1-8) But testing these medicines has practical, ethical and information challenges that need early, careful planning.(9)
How our child-friendly information can help your study
Many of Jane’s clients say their paediatric studies significantly improved as a result of Jane’s writing services. When study materials were written in age-appropriate language, costly delays were avoided because:
- Ethics committee/IRB applications were smoother and faster
- Informed consent/assent discussions at site were much easier
- Metrics for recruitment and compliance improved
Your paediatric writing service
Specialist writer Jane Lamprill ‘translates’ medical information into easier language, for young research participants and their parents. Please get in touch if you’d like help with:
- Age-specific, easy language information for children aged 6+
- Artwork assent materials for children aged 3+
- Wording for informed consent, assent and dissent.
- Non-technical research info for parents/young adults.
Other paediatric writing services
- Medical device SSCP summaries for parents/childen.
- Medicines info/user instructions in easier language
- Other study info for parents e.g social science, psychology etc
- Copy writing for for pharma/patient organisation websites etc.
- EU paediatric trial lay summaaries - please see link
References and useful information
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1 |
2000 |
Conroy S et al |
Survey of unlicensed and off label drug use in paediatric wards in European countries.
BMJ 2000 Jan 8;320 (7227):79-82 |
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2 |
1999 |
UK Parliament Speech by Andrew Love MP. Verbatim account from Hansard, House of Commons. |
Medicines (Children) debate: A teenager in Mr Love’s constituency died after taking medicine for acne that was only licensed for use in adults. He called for new legislation for pharmaceutical companies to make safe, effective medicines for children. |
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3 |
2006 |
European Parliament and European Council |
Regulation (EU) 1901/2006 on medicinal products for paediatric use and amending Regulation (EEC) No 1768/92, Directive 2001/20/EC, Directive 2001/83/EC and Regulation (EC) No 726/2004 |
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4 |
2019 |
USA Susan McCune, M.D. Director, Office of Pediatric Therapeutics, Office of the Commissioner, FDA |
FDA Overview of the Pediatric Legislation |
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5 |
2020 |
UK Medicines and Healthcare products Regulatory Agency |
EU Exit and post-transition guidance, UK Paediatric Requirements - Webinar October 2020 |
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6 |
2020 |
UK Medicines and Healthcare products Regulatory Agency |
EU guidance documents referred to in the Human Medicines Regulations 2012 as amended. (See 50A-50D for UK Paediatric Investigation Plans) |
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7 |
2021 |
UK Medicines and Healthcare products Regulatory Agency |
Procedures for UK Paediatric Investigation Plan (PIPs) |
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8 |
2021 |
UK Medicines and Healthcare products Regulatory Agency |
Completed Paediatric Studies - submission, processing and assessment |
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9 |
2020 |
EU European Medicines Agency |
Preparedness of medicines’ clinical trials in paediatrics |
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