Current state and challenges for plain-language summary development in Japan: Poster supplementary information.

OBJECTIVE: Plain-language summaries (PLSs) are considered pivotal for patient engagement and accessibility of scientific research. We aimed to understand the current state and challenges for PLS development in Japan. RESEARCH DESIGN AND METHODS: Medical Affairs (MA) representatives from seven domestic and two global pharma companies in Japan were interviewed to assess their understanding of Japan’s regulatory requirements and stakeholder expectations around PLSs; their company’s policies, processes, and challenges for PLS development; types of PLSs developed (clinical trial or journal article PLSs); and the future of PLS in Japan. RESULTS: While interviewees acknowledged the importance of PLSs, PLS development for unapproved drugs is not mandatory in Japan. Clinical trial PLSs are more common than journal article PLSs and are typically developed to update trial participants, not for publication. PLS development is more commonly undertaken in global companies, initiated by clinical teams as part of clinical trial standard operating procedures, with Japanese counterparts localizing globally released PLSs. Challenges for PLS development in Japan include: - regulations prohibiting direct communication from pharma companies to patients; - balance between transparency and promotion; - fear of misinformation spreading through divulging early clinical trial results to patients; - terminology/lexicon development to accurately convey technical terms in simple Japanese; - including PLSs within MA scope and providing adequate training; and - few strong, structured patient advocacy groups. CONCLUSIONS: While Japanese pharma recognizes the need for patient engagement, regulatory reforms are required to overcome the current challenges with PLS development. The growing influence of patient advocacy groups and global legislations such as the EMA mandate may provide an impetus to such reforms.