Please Read Carefully (Lay language communications). Parents and children are anxious and vulnerable when unwell.
All clinical studies, especially those testing medicines for sick children, must be performed to the highest ethical, clinical and safety standards.

Paediatric Research CommunicationsTM

Welcome! Paediatric Research CommunicationsTM was born as Paediatric Research ConsultancyTM in 2004, and is now part of Please Read Carefully.TM  Owner Jane Lamprill was a paediatric healthcare professional and is now a specialist writer for adults and children.

Paediatric medicines reseach - the information gap

Pharmaceutical companies are now required to make medicines especially designed for children as well as those for adults.(1-8)  But testing these medicines has practical, ethical and information challenges that need early, careful planning.(9)

How to avoid loss of time, money - and possibly life

Paediatric clinical trials (studies) have tight deadlines e.g. to comply with Paediatric Investigation Plans.(3)  Costly delays occur when Patient Information materials are too technical for meaningful Informed Consent or Assent:

Please scroll down for help.

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. Many clients say that their studies had a smoother ethics review and better study metrics as a result of Jane’s services.

Other paediatric writing services

Lay language communications: grandfather and small boy wait in a clinic room
Jane Lamprill can work with your team to write lay (plain) language summaries for adults and older children.

Help with pediatric lay summaries


The EU/536/2014 Clinical Trial Regulation (11)
will come ‘into application’ on 31 January 2022. Pharmaceutical companies must upload lay summaries of all clinical study results, onto the public section of the European Medicines Agency’s (EMA) database.

This applies to adult and paediatric medicines tested anywhere in the world, if part of a Marketing Authorisation Application in Europe.

ISRCTN Registry: this ‘International Standard Randomised Clinical Trial Number’ will apply from early January 2022. All UK ethically approved clinical trial medicines’ research will be registered automatically at a ‘one-stop-shop’. This  includes for the Health Research Authority, Medicines and Healthcare Products Regulatory Agency (MHRA) and the World Health Organisation. Lay summaries are required for the proposed research, and for the results.

Feel free to get in touch if you need help with lay summaries for:

Jane Lamprill RN RSCN FICR

Jane has written easy-language study info for parents and children since 2002. She gained the Plain English Diploma in 2020 and has many years’ experience working with families and children. Jane also trained at Great Ormond Street Hospital for Children London, and enjoyed being a Paediatric Research Sister (Senior SSC).

Jane also worked for the pharmacutical industry as a freelance Paediatric Research Advisor for 15 years, and has a children’s writing background.

References and useful information

1
2000
Conroy S et al
Survey of unlicensed and off label drug use in paediatric wards in European countries.
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
10
2016
EU
European Commission
Jane Lamprill‘s response to EU consultation. Summary of Clinical Trial Results for Laypersons. 2016
11
2014
EU
European Commission
The Clinical Trials Regulation (EU) 536/2014 will require lay summaries of all EU clinical trial results, to be made available on a public database.
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