PLoS ONE (Jan 2014)

High rate of awarding compensation for claims of injuries related to clinical trials by pharmaceutical companies in Japan: a questionnaire survey.

  • Chieko Kurihara,
  • Hideo Kusuoka,
  • Shunsuke Ono,
  • Naoko Kakee,
  • Kazuyuki Saito,
  • Kenji Takehara,
  • Kiyokazu Tsujide,
  • Yuzo Nabeoka,
  • Takuya Sakuhiro,
  • Hiroshi Aoki,
  • Noriko Morishita,
  • Chieko Suzuki,
  • Shigeo Kachi,
  • Emiko Kondo,
  • Yukiko Komori,
  • Tetsu Isobe,
  • Shigeru Kageyama,
  • Hiroshi Watanabe

DOI
https://doi.org/10.1371/journal.pone.0084998
Journal volume & issue
Vol. 9, no. 1
p. e84998

Abstract

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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.