Abstract
In recent decades, efforts to involve patients/citizens as important stakeholders in the drug development process have evolved. Originally, patient involvement activity started in the AIDS drug development programs. Reflecting the accumulated efforts of internationally active NPOs and other organizations, patient voices are now expanded in the drug development process. During the COVID-19 pandemic, new approaches, such as decentralized clinical trials (DTC) utilizing digital tools, were substantially facilitated. In such an environment, participants should have relatively high digital literacy. There were some findings that some of the recently performed DCTs were questionable from the perspective of patients’ diversity. Also, barriers still exist in educating patients about clinical trials and drug development procedures, which is necessary for them to participate in the sponsor’s activities of PPI and in obtaining educational opportunities. From the perspective of access to vaccines and therapeutics trials during the pandemic situation, the goal of the patient involvement process should essentially be the benefit sharing the society. Ensuring fair treatment opportunities for patients is also very important in the drug development process. This chapter introduces actual patient–public engagement activities in the drug development process as a social co-creation resulting from cooperation among relevant stakeholders.
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Acknowledgments
The authors would like to express our deep gratitude to the clinical trial ambassador project 2022 members, especially Mr. Yuta Kasai (Astellas Pharma Inc.), Mr. Kenma Nozaki (Nippon Boehringer Ingelheim Co. Ltd.), Mr. Shintaro Omuro (Astellas Pharma Inc.), Ms. Keiko Omomo (CMIC HealthCare Institute Co., Ltd.) and Mr. Nobutaka Yagi (Nippon Boehringer Ingelheim Co. Ltd.).
Conflict of Interest
Naoki Tsutsumi, Keiko Inoue, Noriko Iwaya, and Kyoko Imamura have no conflict of interest to be declared related to this manuscript. Kotone Matsuyama received honoraria from Nippon Kayaku Co. Ltd., Astellas Pharma Inc., and Nippon Boehringer Ingelheim Co. Ltd.
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Matsuyama, K., Tsutsumi, N., Inoue, K., Iwaya, N., Imamura, K. (2023). Patient and Public Involvement (PPI) and Pharmaceutical Development Through Open Innovation Processes: Recent Activities. In: Kurihara, C., Greco, D., Dhai, A. (eds) Ethical Innovation for Global Health. Springer, Singapore. https://doi.org/10.1007/978-981-99-6163-4_16
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