Lay and plain language summaries
- Do you need help writing scientific information for the public?
-
Specialist Health Writer Jane Lamprill is happy to advise.
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
- EU Clinical Trial Results (4-9)
- UK ISRCTN Registry (13,14)
- Non-technical language for:
- Adult clinical trial summaries
- Paediatric (pediatric) lay summaries
- Summaries for children aged 6-17yr
Plain language publication summaries
- Medical journal research summaries
- Clear info for people with disabilites
- Plain language summaries for children
- Plain language patient engagement
- Plain language author reviews
- Plain language focus group reviews
Medical device SSCP summaries
- EU Medical Device Summaries (12)
- for Safety & Clinical Performance
- Plain language info for patients
- SSCP readability assessments
- SSCP user-testing & rewrites
- SSCP reports for Notified Bodies
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:
- One year - adult studies
- Six months - paediatric studies
- Thirty months - phase 1 healthy volunteer studies
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
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1 |
2021 |
National Literacy Trust |
Adult literacy: Information on adult literacy in the UK and the Books Unlocked programme |
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2 |
2021 |
NIH National Library of Medicine |
Introduction to health literacy |
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3 |
2018 |
Biros, M |
Capacity, Vulnerability, and Informed Consent for Research |
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4 |
2021 |
European Society of Medical Oncology (ESMO) |
Public policy: EU Clinical Trials Regulation. (A quick overview) |
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5 |
2014 |
European Parliament and the Council
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Clinical Trial Regulation (EU) No 536/2014
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6 |
2022 |
Future Medicine |
Plain language summaries of publication articles |
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7 |
2021 |
European Commission
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Guidance: Good Lay Summary Practice (Eudralex Vol 10, Chapter V additional documents) |
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8 |
2009 |
European Commission
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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 |
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9 |
2017 |
European Commission
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Summaries of Clinical Trial Results for Laypersons |
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10 |
2016 |
European Medicines Agency
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ICH E6 (R2) Good clinical practice
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11 |
2021 |
European Commission Directorate-General for Research & Innovation.
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Horizon Europe Programme: Advice for funding applicants |
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12 |
2019 |
European Commission |
MDCG- 2019-9 Summary of Safety and Clinical Performance. A guide for manufacturers and Notified Bodies |
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13 |
2021 |
BMC - Springer Nature |
ISRCTN Registry for UK clinical trial registration and reporting of results |
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14 |
2021 |
UK Health Research Authority |
Make it Public: transparency and openness in health and social care research |