Medical Writing Writing for Lay Audiences Layperson summaries of clinical trial results: Useful resources in the vacuum of regulatory guidance

Volume 24, Issue 4 - Writing for Lay Audiences

Layperson summaries of clinical trial results: Useful resources in the vacuum of regulatory guidance


To meet the requirements of the clinical trial regulation, preparation for the publication of lay summaries on the European database should be undertaken as soon as possible. However, as of July 2015 (at the time of writing this article), no regulatory guidance has been produced. The main goal of this article is to raise awareness of other resources that writers can use in the interim. This includes templates, guidance, and examples published by the Harvard Workgroup and the Center for Information and Study on Clinical Research Participation, whose work is supported by the EMA and FDA.

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Writing for lay audiences
President's Message
Writing for lay audiences: A challenge for scientists
Patient education accessibility
Legislation and the lay audience: Challenges of communicating benefit and risk in the light of new regulations
Medical writing for two audiences – The RMP public summary
Layperson summaries of clinical trial results: Useful resources in the vacuum of regulatory guidance
Package leaflets for medication in the EU: The possibility of integrating patients’ perspectives in a regulated genre?
What do writers need to know about user testing?
Medical journalism: Another way to write about science
Elements of storytelling in medical journalism
A stroll through the medical blogosphere
Writing narrative style literature reviews
News from the EMA
Profile: An interview with Laura Carolina Collada Ali: On the peculiarities of working for independent research organisations
The Webscout
In the Bookstores
Regulatory Writing
Lingua Franca and Beyond
Gained in Translation
English Grammar and Style
Out On Our Own


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