Drug Evaluation Committee Results of Questionnaire on Preparation and Sharing of Clinical Trial Results
Data Science Subcommittee
August 2025
In recent years, efforts to share the results of clinical trials to trial participants have been regulated in Europe and have attracted more attention than ever before, following their mention in ICH E8 (R1) and E6 (R3). In line with this, various activities are underway to communicate clinical trial results to patients and the public (non-professionals), including the provision of easy-to-understand clinical trial results (lay summaries).
In Japan, one of the ways to know the results of clinical trials is through the Japan Registry of Clinical Trials (jRCT), a system for the submission and publication of clinical research. At present, however, most of the publicly available information contains contents that are not easily understood by non-specialists and expressions that are difficult to understand. In addition, the fact that the results of clinical trials are publicly available itself is not fully recognized by non-specialists.
In light of these circumstances, we conducted a questionnaire survey on the creation and sharing of clinical trial results, including lay summaries, for non-specialists in Japan, and summarized the results. We hope that the results of this survey will help promote consideration of the creation and sharing of clinical trial results for non-specialists in each company.
Japan Pharmaceutical Manufacturers Association, Committee on Drug Evaluation
Data Science Subcommittee 2024 Task Force 2-3
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