Public Attitudes Toward the Secondary Uses of Patient Records for Pharmaceutical Companies’ Activities in Japan

Haruka Nakada, Yusuke Inoue, Keiichiro Yamamoto, Kenji Matsui, Tsunakuni Ikka, Shimon Tashiro

研究成果: Article査読


Objective: The objective of this study is to assess public attitudes toward pharmaceutical companies’ secondary uses of patient records and public preferences regarding consent approaches. Method: 3000 responses to an online survey were collected from adults in Japan. The questionnaire included 32 items related to (1) awareness of “clinical trials”; (2) awareness of the processes of drug development, such as cost, time, and the number of candidate substances in a new drug; (3) knowledge of the laws and regulations for use of patient records in Japan; (4) assessment of the public benefit of the secondary use of patient records; (5) preferences for consent for the secondary use of patient records; and (6) basic characteristics of the respondents. Results: The public benefit from secondary use of records by academic institutions for scientific research was rated highest. All of the activities by pharmaceutical companies were rated higher than those by governmental institutions and other for-profit companies. Regarding consent approaches, 37.9% preferred an “opt-in” approach for new drug development by pharmaceutical companies, 79.7% of whom would change their preference to an “opt-out” approach under specific conditions, such as ensuring intended uses only. Conclusion: Our respondents consider the “public benefit” as dependent on the relative distance from “promoting public health” when assessing the secondary purpose of patient record use. Pharmaceutical companies should include the beneficial purposes when using patient records with “opt-out” approach. Policy makers should pay more attention to the purposes of use when developing personal information protection policies.

ジャーナルTherapeutic Innovation and Regulatory Science
出版ステータスAccepted/In press - 2019

ASJC Scopus subject areas

  • 薬理学、毒性学および薬学(その他)
  • 公衆衛生学、環境および労働衛生
  • 薬理学(医学)


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