Abstract
Background : The Drug Use-Results Surveys(DURSs)is complicated owing to the importance of post-marketing evidence. Consequently, some DURSs deviate from the scope of routine clinical practice. Furthermore, the results are used not only for reexamination and reevaluation by the regulatory authority, but also for academic papers and conference presentation. Therefore, the ethical consideration for patients is vital; however, no regulations for informed consent(IC)and ethical review(ER)are administered in Japan. Methods : We conducted a questionnaire survey on IC and ER in the DURSs of 109 companies and 1274 hospitals in Japan. Results : Overall, we collected information from 63 companies and 362 hospitals. Fifty-eight companies and 341 hospitals had conducted DURSs from 2016 to 2019. Among these, 60.3% companies and 77.5% hospitals took into consideration the requirements for IC. The need for ER was considered by 32.8% companies and 73.1% hospitals. There was a significant difference in the ratio of companies and hospitals that considered IC and ER(p=0.017, p<0.001). In addition, the perspectives were different. Hospitals were cautious with regards to the contents (p<0.001)and ascribed significantly importance to IC and ER(p=0.001, p<0.001). Conclusions : Many companies and hospitals considered the requirement of IC and ER in DURSs. However, the points of deliberation differed. Therefore, a unified regulation should be established.
Translated title of the contribution | Comparative Study of Informed Consent and Ethical Review in the Drug Use-Results Survey using a Nationwide Questionnaire Survey of Pharmaceutical Companies and Hospitals |
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Original language | Japanese |
Pages (from-to) | 159-167 |
Number of pages | 9 |
Journal | Japanese Journal of Clinical Pharmacology and Therapeutics |
Volume | 53 |
Issue number | 5 |
DOIs | |
Publication status | Published - 2022 |
All Science Journal Classification (ASJC) codes
- Pharmacology
- Pharmacology (medical)