Medical Writing Preclinical Studies Creation of a patient-centric patient lay summary in the local language

Volume 26, Issue 4 - Preclinical Studies

Creation of a patient-centric patient lay summary in the local language


Prior to this project, no patient lay summary (PLS) had ever been developed locally in Japan. In order to create a PLS that is more tailored to local patients, we attempted to develop one in and for Japanese. Such PLS was drafted based on the disclosed summary of the clinical study report. We took a composite approach in refining the PLS by researching on lay language and patient-friendly designs. At the same time, we ensured scientific accuracy through consultation with experts such as physicians and statisticians, practised diligence on regulatory and legal aspects, and incorporated patient’s voice by consulting a local patient advocacy group. We successfully created a PLS in the Japanese language for the first time, which was more patient centric than those translated from another language.
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Preclinical studies
President’s Message
EMWA celebrates 25 years
Preclinical research in drug development
An introduction to little-known aspects of nonclinical regulatory writing
Reporting of preclinical research: What do we get told – when and how?
Mind the gap – towards complete and transparent reporting of animal research
The reproducibility crisis in preclinical research – lessons to learn from clinical research
Nonclinical studies in the Russian Federation — Problems, regulatory norms, and harmonisation with international standards
How to survive Brexit as an independent medical writer
Creation of a patient-centric patient lay summary in the local language
Six communication rules for scientific presentations and writing
So, you want to be a medical journalist?
News from the EMA
Profile: An interview with Steven Walker
Getting Your Foot in the Door
In the Bookstores
Journal Watch
The Webscout
Good Writing Practice
Medical Communications
Out on Our Own


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