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

Abstract

IntroductionInternational 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.MethodQuestionnaire surveys were sent to pharmaceutical companies and medical institutions, focusing on industry-initiated clinical trials aiming at new drug applications (NDAs) on patient volunteers in Japan.ResultsWith 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.ConclusionOur 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.

Insurance in clinical research

“…[ 12 ] In Japan, the rate of compensation is higher, raising the doubt of overestimating trial related injuries. [ 13 ]…”

Appropriateness of no-fault compensation for research-related injuries from an African perspective: an appeal for action by African countries: Table 1

“…With this directive, research ethics committees in EU member countries are mandated by law to authorise a clinical trial only if ‘provision has been made for insurance or indemnity cover the liability of the investigator and sponsor’. Similarly in Japan, the guidelines by the Japan Pharmaceutical Industry Legal Affairs Association, developed in 1999 and revised in 2009, mandate research sponsors to contribute to the cost of treatment for clinical trial RRI as a part of compensation and also monetary compensation for death or disability to be provided by the sponsor 42. Through this legally enforced system, Japan boasts of probably the highest rate of compensation for clinical trial-related injuries; 99% of all injuries were compensated according to one report 42.…”

“…Similarly in Japan, the guidelines by the Japan Pharmaceutical Industry Legal Affairs Association, developed in 1999 and revised in 2009, mandate research sponsors to contribute to the cost of treatment for clinical trial RRI as a part of compensation and also monetary compensation for death or disability to be provided by the sponsor 42. Through this legally enforced system, Japan boasts of probably the highest rate of compensation for clinical trial-related injuries; 99% of all injuries were compensated according to one report 42. Such success stories from legislation of compensation policies should act as an example for African countries.…”