Employees of Pfizer Japan recently published their experiences of developing the first Japanese patient lay summary.
The article can be downloaded from the EMWA journal website here.
The authors considered the following elements to be important during the development of their lay summary:
- Font and colour of text
- Line spacing
- Colour scheme
- Page layout
- Ease of comprehension
- Drafting process
- Delivery to patients
- Consultation of experts and patients
- Avoidance of promotional tone
The authors also provided a number of helpful recommendations that they believe are important for future work in this area:
- Establish an eﬀective way to confirm that the patient lay summary does not violate the promotional code
- Ensure compliance with local regulations and practices
- Assess medical and statistical content in lay language
- Find an eﬀective way to involve principal investigators
- Establish a good relationship with patient advocacy groups in Japan
- Increase patient involvement in preparing the ICDs to promote patient centricity
- Collaborate with regulators to establish a framework for clinical trial results disclosure in the industry
- Improve medical writing skills in lay language/ local language
Great to see lay summary content appearing in peer-reviewed literature!