“FY2024 Assembly of the Drug Evaluation Committee” Held “Patient and Public Involvement: A Current Perspective—For Whom Are Our Activities?”

Ms. Matsumoto, who serves as Chairperson of the Ehime Cancer Patients and Families Association “Orange no Kai” and as Vice Chairperson of the National Federation of Cancer Patient Organizations, delivered a presentation drawing on her personal experience of undergoing chemotherapy for cervical cancer.

During the lecture, Mr. Matsumoto posed the question of whether pharmaceutical companies might be placing too much emphasis on “what” to communicate when providing information.She expressed the view that it is most important to be mindful of “for whom” the information is intended and “what kind of information” is being conveyed. She emphasized the need to “show” rather than simply “make people read” the information to encourage a desire to engage with it; to convey content based on scientific evidence using plain language; and to enable patients to view the issue as “their own” problem so they can make appropriate choices.

The presentations prompted each attendee to reflect deeply on topics such as “Who are ‘patients’?”; the message that “patients cannot be reduced to mere numbers, as each individual is unique”; the difficulty of accessing accurate information given the diverse circumstances of readers; and the importance of presenting information in a way that takes readers’ emotions into account.

Ms. Muto delivered an insightful lecture from an academic perspective on the theme of pharmaceuticals and patient and citizen engagement.

The session began with an explanation based on the latest findings regarding how to describe patient and public participation, and the view was presented that patient and public participation in research and development is referred to as “Patient and Public Involvement and Engagement (PPIE).”

At PPIE, he expressed the view that it is crucial for patients and researchers to collaborate at every stage of the drug development process, engaging in “meaningful” discussions rather than simply concluding with “Thank you for your valuable feedback,” so that patients’ voices are reflected in drug development and lead to the provision of better healthcare services.Finally, the presentation concluded with a message emphasizing the importance of continuing to build upon best practices in patient and citizen engagement, with the goal of realizing the kind of healthcare that patients desire in the development and use of pharmaceuticals.

The Patient Cooperation Committee was established in 2012, but the initiatives that form its foundation date back to 1999. Currently, its objective is to work in collaboration with patient organizations to realize “patient-participatory healthcare.”

In his presentation, Chairperson Misawa first provided an overview of the committee, including its vision for the end of fiscal year 2025 and its organizational structure. He then introduced specific initiatives aimed at achieving this vision.Specifically, a wide range of activities were introduced, including the formulation of “Guidelines on Collaboration with Patient Organizations” and “Transparency Guideline”; conducting surveys on the awareness and activities of patient organizations; establishing an advisory board; hosting seminars for patient organizations; providing information on the website; supporting the operations of the “Association for Creating a Society Where Everyone Has Easy Access to Clinical Trials”;and providing operational support for the “Medicine Visionary Conference,” among other activities covering a very wide range of areas.

Through these presentations, the message was conveyed that collaboration among various stakeholders—including patient organizations and pharmaceutical companies—plays a crucial role in realizing a better healthcare environment.

Chairperson Nakaji introduced the FY2024 activity policies and initiatives, providing an overview of PPI activities within the Drug Evaluation Committee and explaining the results of surveys and questionnaires conducted among citizens and patients. She identified the following challenges based on the results: issues regarding access to information (inability to find reliable information, poor usability of information websites),and issues regarding information content (insufficient information and information that is difficult to understand). This was followed by explanations of regulatory authorities’ initiatives, efforts related to the drug discovery ecosystem, JPMA’s website, and the disclosure of information via social networking services (SNS).

Finally, based on the results of previous surveys, which revealed challenges regarding access to clinical trial information and the quality of content, a policy was outlined to continue prioritizing dialogue with patients and the public and to improve the provision of information, with the aim of promoting participation in clinical trials and enhancing pharmaceutical literacy.Furthermore, the presentation concluded by expressing the expectation that these efforts will contribute to nationwide initiatives to strengthen drug discovery capabilities and eliminate drug lag and drug loss.

Subcommittee Chair Matsuzawa explained that the Clinical Evaluation Subcommittee has established “Vision 2025” as its guiding principle, which includes advancing drug development in collaboration with patients, and he outlined the action plan and task force activities aimed at achieving this goal.Based on the results of a survey of member companies of the Clinical Evaluation Subcommittee of the JPMA Drug Evaluation Committee, it was noted that while PPI initiatives are progressing, they are still insufficient, as indicated by data showing changes over time in each company’s PPI efforts.As specific actions, presentations were given on the utilization of digital transformation (DX) overseas, decentralized clinical trials (DCTs) designed to be patient-centered, and The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) Topic E22, “General Guidance on Patient Preference Trials.”

Finally, we declared our commitment to continuing PPI-focused activities to deliver innovative and highly effective pharmaceuticals more quickly to patients, healthcare professionals, and people around the world.

At the outset, Subcommittee Chair Miyazaki introduced efforts to raise awareness of pharmacovigilance activities, including the writing of textbooks for students and healthcare professionals. Next, following an explanation of the status of Risk Management Plan (RMP) development, the question was raised as to whether the information provided to patients through regulatory requirements alone is sufficient.In addition, the results of an analysis on how patients, physicians, and pharmacists obtain safety information were presented, along with findings regarding the gap between patient needs and the actual explanations provided by physicians and pharmacists. Bearing in mind that patients also access information directly from pharmaceutical companies, the discussion addressed whether the information provided by each company meets patient needs,whether the media used (digital or print) are appropriate, and whether the delivery methods are tailored to patients’ IT literacy levels and specific conditions.

Chairman Aoyama introduced the overall activities of the Medical Affairs Subcommittee and initiatives related to patient-centric care (Patient Centricity).According to a survey of member companies of the Medical Affairs Subcommittee of the JPMA Drug Evaluation Committee, while many pharmaceutical companies are engaged in patient-centricity activities, challenges such as a lack of implementation experience and insufficient internal guidelines have also come to light.In response, the Medical Affairs Subcommittee compiled a collection of case studies covering topics such as “Points to Note When Medical Affairs Departments Conduct Disease Awareness Activities Targeting Patients.”

Furthermore, based on the results of interviews with patient organizations, the importance of continuity in information dissemination and the creation of materials that reflect patients’ voices was highlighted. In addition, the current status of a task force examining disease awareness activities targeting patients and others was presented.

To conclude, the Medical Affairs Subcommittee declared that, as part of its future initiatives, it aims to create an environment where patients can access accurate information and to realize a society where patients can undergo treatment with confidence.