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. 2014 Jan 8;9(1):e84998.
doi: 10.1371/journal.pone.0084998. eCollection 2014.

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

Chieko Kurihara  1 , Hideo Kusuoka  2 , Shunsuke Ono  3 , Naoko Kakee  4 , Kazuyuki Saito  5 , Kenji Takehara  4 , Kiyokazu Tsujide  6 , Yuzo Nabeoka  7 , Takuya Sakuhiro  8 , Hiroshi Aoki  6 , Noriko Morishita  9 , Chieko Suzuki  10 , Shigeo Kachi  10 , Emiko Kondo  11 , Yukiko Komori  12 , Tetsu Isobe  13 , Shigeru Kageyama  14 , Hiroshi Watanabe  15
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High rate of awarding compensation for claims of injuries related to clinical trials by pharmaceutical companies in Japan: a questionnaire survey

Chieko Kurihara et al. PLoS One. .

Abstract

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 industry-initiated 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.

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Conflict of interest statement

Competing Interests: KT is an employee of Pfizer Japan Inc., YN is an employee of Chugai Pharmaceutical Co., Ltd., TS is an employee of Mitsubishi Tanabe Pharma Corporation, HA is an employee of Teikoku Seiyaku Co., Ltd., KT and HA are on the board of Clinical Evaluation Expert Committee, Drug Evaluation Committee, Japan Pharmaceutical Manufacturers Association. This does not alter our adherence to all the PLOS ONE policies on sharing data and materials. There is no other competing interest to be declared according to the policy of PLOS ONE.

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References

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    1. Directive 2001/20/EC of the European Parliament and of the Council of 4 April 2001 on the approximation of the laws, regulations and administrative practice in the conduct of clinical trials on medicinal products for human use (2001) Official Journal of the European Communities L. 121: 34–44.
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