Assembly of the Drug Evaluation Committee for 2024 Patient and Public Involvement" - For Whom We Work

Dr. Matsumoto, who also serves as the president of Ehime Cancer Patients and Families Association "Orenji no Kai" and vice president of National Federation of Cancer Patients Associations, gave a lecture from the perspective of having experienced anti-cancer drug treatment for cervical cancer herself.

During the lecture, Mr. Matsumoto asked the audience whether pharmaceutical companies are focusing on "what" to communicate in providing information. He also stated that the most important thing is to "show" rather than "make" information be read, and to provide information based on scientific evidence in plain language so that patients can think of it as their own problem and make an appropriate choice. The patient should be able to think of it as "my" problem and make an appropriate choice.

Who are Patients? The lecture provided an opportunity for each participant to think deeply about the message that "Patients are not a number that can be rounded up, but are different for each individual," the difficulty of reaching correct information under different circumstances of readers, and the importance of presenting information in a way that takes readers' emotions into consideration.

Dr. Muto gave a thought-provoking lecture on the theme of pharmaceuticals and patient/citizen participation from an academic perspective.

At the beginning of the panel discussion, the latest findings on how to describe patient and public involvement were explained, and the view that patient and public involvement in research and development should be described as "Patient and Public Involvement and Engagement (PPIE)" was presented.

The PPIE presented the idea that it is important for patients and researchers to cooperate at all stages of the drug development process, to have "Meaningful: meaningful" discussions that do not end with "Thank you for your valuable input," and to ensure that patients' voices are reflected in drug development and the realization of better medical service delivery. He also expressed his thoughts on the importance of having "Meaningful" discussions and ensuring that patients' voices are reflected in the development of drugs and the provision of better medical services. He concluded his lecture with the message that it is important to continue to accumulate good examples of patient and citizen participation and to aim for the realization of medical care that patients want in the development and use of pharmaceutical products.

The Patient Cooperation Committee was established in 2012, but its base efforts date back to 1999. Currently, the committee aims to work with patient groups to realize "patient-participatory medicine.

In his speech, Chairperson Misawa first gave an overview of the committee, including the ideal state of the committee by the end of FY2025 and its organizational structure. Then, he introduced specific initiatives to achieve the ideal state. Specifically, the committee formulated "Guidelines for Collaboration with Patient Groups" and "Transparency Guideline for the Relationship between Corporate Activities and Patient Groups," conducted a survey on the awareness and activities of patient groups, established an advisory board, held seminars for patient groups, provided information on its website, and provided operational support for the "Society for Creating Accessible Clinical Trials for All. The committee introduced a very wide range of activities, including support for the operation of the "Association for Creating a Society with Easy Access to Clinical Trials" and the Pharmaceutical Visionary Conference.

Through his presentation, Dr. Kato's message was that collaboration among various stakeholders, including patient groups and JPMA, will play an important role in realizing a better healthcare environment.

Chairperson Nakaji introduced the activities and policies for FY2024, outlining the PPI activities of the Drug Evaluation Committee and the results of the surveys and questionnaires conducted among the public and patients. The results of the survey showed that there are issues related to access to information (not being able to access reliable information, low usability of information websites) and information content (insufficient amount of information, information is difficult to understand). Then, he explained about the efforts of regulatory authorities, drug discovery ecosystem, JPMA's website, and information disclosure using SNS (Social Networking Service).

Finally, the results of the survey to date indicate that there are issues with access to clinical trial information and the quality of its content, and the panel indicated that they will continue to emphasize dialogue with patients and the public and improve the provision of information, with the aim of promoting participation in clinical trials and improving drug literacy. He also concluded his presentation by expressing his hope that the committee will contribute to the national effort to strengthen drug discovery and eliminate drug lag/loss.

Mr. Matsuzawa, Chairperson of the Committee, explained that the Clinical Evaluation Committee has established "Vision 2025" as its activity policy, and is working on it with the goal of promoting drug development together with patients, and explained the action plan and task force activities toward that goal. According to the results of a questionnaire survey of member companies of the Clinical Evaluation Subcommittee of the JPMA Drug Evaluation Committee, data on the status of PPI efforts by each company over time showed that efforts are progressing, but are not yet sufficient. Specific actions include the use of DX (Digital Transformation) overseas, DCT (Decentralized Clinical Trial) for patient-oriented clinical trials, ICH (International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use), and the new topic E22 "General Guidelines for Patient Preference Trials".

Finally, he declared that we will continue our activities with PPI in mind in order to deliver innovative and highly useful medicines to patients, healthcare professionals, and people around the world more quickly.

Section Chair Miyazaki began the session by introducing the activities of writing textbooks for students and medical professionals as part of efforts to raise awareness of pharmacovigilance activities. Next, after explaining the status of preparation of the Risk Management Plan (RMP) for pharmaceuticals, the question was raised as to whether the information provided to patients is sufficient only by providing information as stipulated by regulations. The results of the analysis of how patients, physicians, and pharmacists obtain safety information and the gap between patients' needs and the actual explanations by physicians and pharmacists were also presented, He also mentioned the need to review whether the medium (digital or paper) is appropriate and whether the information provided is in line with IT literacy and disease.

Mr. Aoyama, Chairperson of the committee, introduced the overall activities of the Medical Affairs Committee and its initiatives on Patient Centricity. According to a questionnaire survey of member companies of the JPMA Drug Evaluation Committee's Medical Affairs Subcommittee, while many pharmaceutical companies are engaged in Patient Centricity activities, some issues such as lack of experience in implementation and lack of internal rules have been highlighted. In response to this, the Medical Affairs Committee has compiled a collection of case studies on "points to note when medical affairs departments conduct disease awareness activities targeting patients" and other issues.

The results of interviews with patient groups also suggested the importance of continuity in information dissemination and the creation of materials that reflect the voices of patients. He also presented the activities of the task force that is studying disease awareness activities targeting patients and others.

As for future efforts, the Medical Affairs Subcommittee concluded with a declaration that it aims to create an environment in which patients can obtain correct information and realize a society in which they can receive treatment with conviction.