Real World Survey of Patient Engagement Status in Clinical Research: The First Input from Japan
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ORIGINAL RESEARCH ARTICLE
Real World Survey of Patient Engagement Status in Clinical Research: The First Input from Japan Nanae Tanemura1 · Tsuyoshi Sasaki2 · Junko Sato1,3 · Hisashi Urushihara1
© Springer Nature Switzerland AG 2020
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.
1 Introduction Patient engagement in clinical research and drug development strategies have a wide range of implications in a variety of therapeutic areas. An absence of patient engagement Electronic supplementary material The online version of this article (https://doi.org/10.1007/s40271-020-00436-5) contains supplementary material, which is available to authorized users. * Hisashi Urushihara [email protected] 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
may have dire consequences for cases in which it is crucial that the patient’s needs be considered. It has also been said that “the role of an ‘engaged’ patient would appear to be a rational, well-informed actor who can relieve the burden caused by the gaps between the regulatory system and clin
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