@article{oai:repo.qst.go.jp:00055903,
 author = {栗原, 千絵子 and et.al and 栗原 千絵子},
 journal = {PLoS ONE (Online only:URL:http://www.plosone.org)},
 month = {Jan},
 note = {Introduction: International norms and ethical standards have suggested that compensation for research-related injury
should be provided to injured research volunteers. However, statistical data of incidence of compensation claims and the
rate of awarding them have been rarely reported.
Method: Questionnaire surveys were sent to pharmaceutical companies and medical institutions, focusing on industryinitiated
clinical trials aiming at new drug applications (NDAs) on patient volunteers in Japan.
Results: With the answers from pharmaceutical companies, the incidence of compensation was 0.8%, including 0.06% of
monetary compensation. Of the cases of compensation claims, 99% were awarded. In turn, with the answers from medical
institutions, the incidence of compensation was 0.6%, including 0.4% of serious but not death cases, and 0.04% of death
cases. Furthermore, most claims for compensation were initiated by medical institutions, rather than by the patients. On the
other hand, with the answers from clinical trial volunteers, 3% of respondents received compensations. These compensated
cases were 25% of the injuries which cannot be ruled out from the scope of compensation.
Conclusion: Our study results demonstrated that Japanese pharmaceutical companies have provided a high rate of
compensation for clinical trial-related injuries despite the possibility of overestimation. In the era of global clinical
development, our study indicates the importance of further surveys to find each country’s compensation policy by
determining how it is being implemented based on a survey of the actual status of compensation coming from statistical data.},
 title = {High Rate of Awarding Compensation for Claims of Injuries Related to Clinical Trials by Pharmaceutical Companies in Japan: A Questionnaire Survey},
 volume = {9},
 year = {2014}
}