Drug Evaluation Committee Workshop "What is a Lay Summary that Responds to "Want to Know"? ～Let's think together from the viewpoints of patients, regulations, and practice! ~"
May 28, 2026
Japan Pharmaceutical Manufacturers Association Drug Evaluation Committee held a workshop on April 16, 2026, in a face-to-face format, as part of the promotion of patient and public involvement in drug development (PPI/E). 23 member companies participated in the workshop. A total of 43 participants and observers from 23 member companies attended. The workshop was designed to promote the creation and sharing of lay summaries of clinical trial results and to discuss what can be done to make lay summaries of clinical trial results more meaningful.
Part 1: Lecture
In the first presentation, he explained the significance of sharing clinical trial results as lay summaries in light of the GCP Renovation, an initiative to review GCP, the international guideline for clinical trials. The concept of patient and public involvement (PPI/E) was incorporated into the basis of ICH E8(R1) and E6(R3) (the revised international guidelines that define the concept of clinical trial planning [E8] and conduct and quality control [E6]), and it was shown that trial participants are positioned as "partners" who are involved together in the generation of evidence. The presentation also showed that sharing the results of a clinical trial as a lay summary is an important feedback to the partners, through which trial participants can realize their contribution to the research, and it can also lead to the understanding and trust of clinical trials among the public and society. He also suggested the importance of understanding the purpose of preparing a lay summary in depth and changing the mindset, rather than viewing it as a formal task.
In lecture 2, based on the "Handling of Information Provision for Clinical Trials, etc." issued in March 2026 (Pharmaceuticals and Medical Devices Agency Publication No. 0330-1 dated March 30, 2026) and related Q&A, he explained the regulations regarding pharmaceutical advertising that should be considered when creating and sharing lay summaries of clinical trial results. The new notice will be effective for "Participants" and "Participants" for "Clinical Trial". The new notice clarifies the framework of "provision of information for participant recruitment" and "provision of information for purposes other than participant recruitment. The new notice clarifies the framework of "providing information for purposes other than participant recruitment" and "providing information for purposes other than participant recruitment," and indicates that the provision of information, including lay summaries of clinical trial results, does not constitute advertising if certain requirements are met. This reiterated that it is possible to create and publish lay summaries by correctly understanding and complying with the new regulations. In addition, specific practical considerations such as the design of the cover page and the content of the description when publishing on the corporate website, as well as the importance of preparing them with reference to the relevant guidelines were introduced.
Part 2: Interview Session
In the second part, Mr. Sumito Nishidate, President of GISTERS, a non-profit organization, was invited to give his opinion in an interview format on the theme of "Significance, usefulness and issues of lay summaries for patients and citizens including clinical trial participants. The following specific opinions were shared regarding the meaning and value of lay summaries for clinical trial participants and their families, as well as comments on the content of information they would like to know about clinical trial results from the perspective of patients and patients' families, including clinical trial participants.
- Clinical Trial Participants are Partners for Companies
- The lay summary is an important resource for each patient's future and life choices
- That they want to know the results, even if the results are negative
- The material should be understandable and shareable not only with the patient but also with family members.
In order to realize such value, the participants were encouraged to consider how to provide easy-to-understand and trustworthy information by cooperating with each other as a common issue, rather than each pharmaceutical company dealing with the issue individually.
Part 3: Group Discussion
In the third part of the session, participants were divided into groups of about five for a group discussion based on the content of the lecture and interview session. After sharing their impressions, the participants discussed what they could do from their own standpoints and created their own action declarations as "next steps.
In terms of promoting the creation and sharing of the Lay Summary, the participants mentioned communicating its significance and value internally, involving like-minded colleagues, and first of all, giving shape to the Lay Summary. On the other hand, from the perspective of making the Ray Summary truly beneficial to patients and the public, the participants developed a declaration of action for each position, such as collaborating internally and externally, and implementing and establishing the Ray Summary as an easy-to-understand and trusted Ray Summary.
In the post-workshop questionnaire, many participants responded that they wanted to further promote their efforts to create and share lay summaries of clinical trial results as a result of this workshop.
Based on the discussions in the day's lectures, interview session, and group discussions, as well as the participants' thoughts, the Drug Evaluation Committee will continue its efforts to promote PPI/E, including lay summaries of clinical trial results.
Presentation materials from the day are posted below.