Please Read Carefully TM | Lay language writing services

Paediatric Research Communications^TM

Welcome - how can we help your pediatric study?

Paediatric Research Communications^TM (formerly Paediatric Research Consultancy^TM) is now part of Please Read Carefully^TM.

Owner & Lay Language Writer Jane Lamprill writes clear, age-appropriate information for children of all ages and cognitive ability. She also has many years’ experience caring for children and their families in hospital and research settings.

Informed consent/assent inforrmation for children

Some pharmaceutical companies save children’s lives by making medicines especially designed for them. But testing these medicines with child volunteers is complex and requires an ethical, family-friendly approach.

Costly research delays can be avoided when information for parents and children is clear, concise and age-appropriate because:

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

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


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	https://pubmed.ncbi.nlm.nih.gov/10625257/" target="_blank">https://pubmed.ncbi.nlm.nih.gov/10625257
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.	https://api.parliament.uk/historic-hansard/commons/1999/apr/19/medicines-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	https://www.ema.europa.eu/en/human-regulatory/overview/paediatric-medicines/paediatric-regulation/paediatric-regulation
4	2019	USA Susan McCune, M.D. Director, Office of Pediatric Therapeutics, Office of the Commissioner, FDA	FDA Overview of the Pediatric Legislation	https://www.fda.gov/media/132890/download
5	2020	UK Medicines and Healthcare products Regulatory Agency	EU Exit and post-transition guidance, UK Paediatric Requirements – Webinar October 2020	https://www.youtube.com/watch?v=3I1IgU-HPj4&feature=youtu.be
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)	https://www.gov.uk/guidance/eu-guidance-documents-referred-to-in-the-human-medicines-regulations-2012
7	2021	UK Medicines and Healthcare products Regulatory Agency	Procedures for UK Paediatric Investigation Plan (PIPs)	https://www.gov.uk/guidance/procedures-for-uk-paediatric-investigation-plan-pips
8	2021	UK Medicines and Healthcare products Regulatory Agency	Completed Paediatric Studies – submission, processing and assessment	https://www.gov.uk/guidance/completed-paediatric-studies-submission-processing-and-assessment
9	2020	EU European Medicines Agency	Preparedness of medicines’ clinical trials in paediatrics	https://www.ema.europa.eu/en/documents/other/preparedness-medicines-clinical-trials-paediatrics-recommendations-enpr-ema-working-group-trial_en.pdf

Paediatric Research CommunicationsTM