Nanae Tanemura1, Tsuyoshi Sasaki2, Junko Sato1,3, Hisashi Urushihara4. 1. Division of Drug Development and Regulatory Science, Faculty of Pharmacy, Keio University, 1-5-30 Shibakoen, Minato-ku, Tokyo, 105-8512, Japan. 2. Department of Child Psychiatry, Chiba University Hospital, Chiba, 260-0856, Japan. 3. Pharmaceuticals and Medical Devices Agency, Tokyo, 100-0013, Japan. 4. Division of Drug Development and Regulatory Science, Faculty of Pharmacy, Keio University, 1-5-30 Shibakoen, Minato-ku, Tokyo, 105-8512, Japan. urushihara.hisashi@keio.jp.
Abstract
BACKGROUND: The updated international draft guidelines, the "General Considerations for Clinical Studies, ICH E8 (R1)", state that patient engagement ensures that all perspectives are captured in the research process; however, this is not well understood, specifically in Japan. OBJECTIVE: This study examined the current status and perceptions of patient engagement in clinical research from the perspectives of patient groups, pharmaceutical corporations, and researchers in Japan, using anonymous self-administered questionnaires. METHODS: Three online surveys were conducted with patient groups (n = 100), pharmaceutical corporations (n = 66), and researchers (n = 300) in May and June 2019. The main variables were the current status and the current perception of patient engagement in clinical research. RESULTS: The response rate was 71% for patient groups and 85% for pharmaceutical corporations, and there were 300 valid responses (emergence rate: 4.9%) from researchers. Experiences with clinical research involving patient engagement were reported by 76.5% of the patients, 21.4% of the pharmaceutical corporations, and 51.7% of the researchers. Patient groups reported three major factors that negatively impacted their relationship with pharmaceutical corporations and researchers: (1) 'lack of understanding of the benefits of partnering'; (2) 'lack of transparency or openness'; and (3) 'unclear or ill-defined processes'. CONCLUSIONS: Pharmaceutical corporations in Japan have less experience with patient engagement in clinical research than other stakeholders. A neutral connecting system among the stakeholders with a constructive co-learning system will allow effective involvement/engagement of patient groups for enhancing the effectiveness of clinical research.
BACKGROUND: The updated international draft guidelines, the "General Considerations for Clinical Studies, ICH E8 (R1)", state that patient engagement ensures that all perspectives are captured in the research process; however, this is not well understood, specifically in Japan. OBJECTIVE: This study examined the current status and perceptions of patient engagement in clinical research from the perspectives of patient groups, pharmaceutical corporations, and researchers in Japan, using anonymous self-administered questionnaires. METHODS: Three online surveys were conducted with patient groups (n = 100), pharmaceutical corporations (n = 66), and researchers (n = 300) in May and June 2019. The main variables were the current status and the current perception of patient engagement in clinical research. RESULTS: The response rate was 71% for patient groups and 85% for pharmaceutical corporations, and there were 300 valid responses (emergence rate: 4.9%) from researchers. Experiences with clinical research involving patient engagement were reported by 76.5% of the patients, 21.4% of the pharmaceutical corporations, and 51.7% of the researchers. Patient groups reported three major factors that negatively impacted their relationship with pharmaceutical corporations and researchers: (1) 'lack of understanding of the benefits of partnering'; (2) 'lack of transparency or openness'; and (3) 'unclear or ill-defined processes'. CONCLUSIONS: Pharmaceutical corporations in Japan have less experience with patient engagement in clinical research than other stakeholders. A neutral connecting system among the stakeholders with a constructive co-learning system will allow effective involvement/engagement of patient groups for enhancing the effectiveness of clinical research.
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