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Real World Survey of Patient Engagement Status in Clinical Research: The First Input from Japan

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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.

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Acknowledgements

The authors are grateful to Dr. Sophia K. Smith from the Duke University School of Nursing for her assistance in this study, and would like to thank Digital Medical Communications (DMC Corp.; www.dmed.co.jp) for providing English language editing. The authors are particularly grateful for the assistance provided by Ms. Ayaka Nakamura.

Author information

Authors and Affiliations

  1. Division of Drug Development and Regulatory Science, Faculty of Pharmacy, Keio University, 1-5-30 Shibakoen, Minato-ku, Tokyo, 105-8512, Japan

    Nanae Tanemura, Junko Sato & Hisashi Urushihara

  2. Department of Child Psychiatry, Chiba University Hospital, Chiba, 260-0856, Japan

    Tsuyoshi Sasaki

  3. Pharmaceuticals and Medical Devices Agency, Tokyo, 100-0013, Japan

    Junko Sato

Authors
  1. Nanae Tanemura
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  2. Tsuyoshi Sasaki
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  4. Hisashi Urushihara
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Contributions

All authors contributed to the study conception and design. Material preparation, data collection, and analysis were performed by all authors. The first draft of the manuscript was written by Nanae Tanemura and all authors provided feedback and suggestions on subsequent versions of the manuscript. All authors read and approved the final manuscript.

Corresponding author

Correspondence to Hisashi Urushihara.

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Funding

This research received two specific grants, from the Research Foundation for Pharmaceutical Sciences in 2019 and the Pfizer Health Research Foundation in 2018.

Conflict of interest

Tsuyoshi Sasaki has received speakers’ honoraria from Daiichi Sankyo, Eli Lilly, GlaxoSmithKline, Novartis, Janssen, Otsuka, Shionogi, Shire, Takeda, Taisho, and Tanabe Mitsubishi, and has also received research support from Novartis, Otsuka, Shionogi, and Taisho (from April 2014 to December 2019). Hisashi Urushihara has received a research grant from Shionogi and Senju Pharmaceutical Corporation, and has also received research funds from Daiichi Sankyo, Tanabe Mitsubishi, and Astellas. Nanae Tanemura and Junko Sato declare no potential conflicts of interest regarding the research, authorship, and/or publication of this article.

Ethics Approval

This survey was approved by the Keio University Faculty of Pharmacy’s Ethics Committee for Research Involving Humans on 18 March 2019 (No. 190318–1). The study was conducted in accordance with the ethical standards laid down in the 1964 Declaration of Helsinki and its subsequent amendments.

Consent to Participate

We posted the general outline of our research at the top of the survey website for the nominated subjects. We considered participants completing the survey as providing consent in accordance with the Ethical Guidelines for Medical and Health Research Involving Human Subjects published by the Ministry of Health, Labor, and Welfare in Japan.

Consent for Publication

Not applicable.

Availability of Data and Material

All relevant data are included within the paper and its supporting information files.

Code Availability

Not applicable.

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Tanemura, N., Sasaki, T., Sato, J. et al. Real World Survey of Patient Engagement Status in Clinical Research: The First Input from Japan. Patient 13, 623–632 (2020). https://doi.org/10.1007/s40271-020-00436-5

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  • DOI: https://doi.org/10.1007/s40271-020-00436-5

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