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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