High Rate of Awarding Compensation for Claims of Injuries Related to Clinical Trials by Pharmaceutical Companies in Japan: A Questionnaire Survey

Introduction: International norms and ethical standards have suggested that compensation for research-related injuryshould be provided to injured research volunteers. However, statistical data of incidence of compensation claims and therate of awarding them have been rarely reported.Method: Questionnaire surveys were sent to pharmaceutical companies and medical institutions, focusing on industryinitiatedclinical 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% ofmonetary compensation. Of the cases of compensation claims, 99% were awarded. In turn, with the answers from medicalinstitutions, the incidence of compensation was 0.6%, including 0.4% of serious but not death cases, and 0.04% of deathcases. Furthermore, most claims for compensation were initiated by medical institutions, rather than by the patients. On theother hand, with the answers from clinical trial volunteers, 3% of respondents received compensations. These compensatedcases 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 ofcompensation for clinical trial-related injuries despite the possibility of overestimation. In the era of global clinicaldevelopment, our study indicates the importance of further surveys to find each country’s compensation policy bydetermining how it is being implemented based on a survey of the actual status of compensation coming from statistical data