Cancer patient at home reading medical informatin with family memberadults - teen with cancer reads medical information with family member
Patients need plain language summaries that are easy to read and understand.

Lay and plain language summaries

Jane can collaborate with your team to produce easy language information for your readers.  She performs all lay summaries for the EU Clinical Trials Regulation database to Good Lay Summary Practice.

Paediatric lay summaries for children will be simplified versions, written in age-appropriate language.

Lay summaries clinical trial results

Lay language communications: Pharmacist explains medicines information in lay language to a femaile customer.

Plain language publication summaries

Please Read Carefully: Research nurse discusses informed consent documents with patients.

Medical device SSCP summaries

Cochlear implant devices
Lay language communications: grandfather and small boy wait in a clinic room
Jane Lamprill can work with your team to write clinical trial lay summareis for adults and children.

Lay summaries | brief overview

From 1 February 2022

The EU/536/2014 Clinical Trial Regulation (5)  requires lay summaries of all clinical trial results to be placed on the EMA ‘s  public database. This applies to all studies for Market Authorisation Applications in Europe. Lay summaries must be posted from the date of last patient last visit after:

The UK ISRCTN Registry:  ‘Make it Public’ is the UK’s Health Research Authority’s new transparency initiative. All UK ethically approved clinical trials must be registered.   Lay summaries are required initially for the proposed studies, and also for the study results.

References and useful information

1
2021
National Literacy Trust
Adult literacy: Information on adult literacy in the UK and the Books Unlocked programme
2
2021
NIH National Library of Medicine
Introduction to health literacy
3
2018
Biros, M
Capacity, Vulnerability, and Informed Consent for Research
4
2021
European Society of Medical Oncology (ESMO)
Public policy: EU Clinical Trials Regulation. (A quick overview)
5
2014
European Parliament and the Council
Clinical Trial Regulation (EU) No 536/2014
6
2022
Future Medicine
Plain language summaries of publication articles
7
2021
European Commission
Guidance: Good Lay Summary Practice (Eudralex Vol 10, Chapter V additional documents)
8
2009
European Commission
Eudralex Volume 10 Guideline 2009/C28/01 on the information concerning paediatric clinical trials to be entered into the EU Database on Clinical Trials (EudraCT) and on the information to be made public by the European Medicines Agency (EMEA) in accordance with Article 41 of Regulation (EC) No 1901/2006
9
2017
European Commission
Summaries of Clinical Trial Results for Laypersons
10
2016
European Medicines Agency
ICH E6 (R2) Good clinical practice
11

2021

European Commission Directorate-General for Research & Innovation.
Horizon Europe Programme: Advice for funding applicants
12
2019
European Commission
MDCG- 2019-9 Summary of Safety and Clinical Performance. A guide for manufacturers and Notified Bodies
13
2021
BMC - Springer Nature
ISRCTN Registry for UK clinical trial registration and reporting of results
14
2021
UK Health Research Authority
Make it Public: transparency and openness in health and social care research
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