Please Read Carefully: doctor reads assent information to little girl
Jane Lamprill provides clinical trial assent information and artwork, for children aged 3-5 years.

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:

Please Read Carefully: Children from several countries hold a large globe of the world
Jane writes ethical, age-appropriate clinical study assent information, for children all over the world.

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:

Other paediatric writing services

References and useful information

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
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.
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
4
2019
USA
Susan McCune, M.D. Director, Office of Pediatric Therapeutics, Office of the Commissioner, FDA
FDA Overview of the Pediatric Legislation
5
2020
UK
Medicines and Healthcare products Regulatory Agency
EU Exit and post-transition guidance, UK Paediatric Requirements - Webinar October 2020
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)
7
2021
UK
Medicines and Healthcare products Regulatory Agency
Procedures for UK Paediatric Investigation Plan (PIPs)
8
2021
UK
Medicines and Healthcare products Regulatory Agency
Completed Paediatric Studies - submission, processing and assessment
9
2020
EU
European Medicines Agency
Preparedness of medicines’ clinical trials in paediatrics
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