title: High rate of awarding compensation for claims of injuries related to clinical trials by pharmaceutical companies in Japan: a questionnaire survey.
abstract: BACKGROUND
  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.
  
  
  METHODS
  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.
  
  
  CONCLUSIONS
  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.
authors.affiliation: Molecular Imaging Center, National Institute of Radiological Sciences, Chiba, Chiba, Japan.
authors.forename: Chieko
authors.initials: C
authors.lastname: Kurihara
authors.affiliation: National Hospital Organization Osaka National Hospital, Osaka, Osaka, Japan.
authors.forename: Hideo
authors.initials: H
authors.lastname: Kusuoka
authors.affiliation: Graduate School of Pharmaceutical Sciences, The University of Tokyo, Tokyo, Japan.
authors.forename: Shunsuke
authors.initials: S
authors.lastname: Ono
authors.affiliation: Department of Health Policy, National Center for Child Health and Development, Tokyo, Japan.
authors.forename: Naoko
authors.initials: N
authors.lastname: Kakee
authors.affiliation: Office of OTC/Generic Drugs, Pharmaceuticals and Medical Devices Agency, Tokyo, Japan.
authors.forename: Kazuyuki
authors.initials: K
authors.lastname: Saito
authors.affiliation: Department of Health Policy, National Center for Child Health and Development, Tokyo, Japan.
authors.forename: Kenji
authors.initials: K
authors.lastname: Takehara
authors.affiliation: Clinical Evaluation Expert Committee, Drug Evaluation Committee, Japan Pharmaceutical Manufacturers Association, Tokyo, Japan.
authors.forename: Kiyokazu
authors.initials: K
authors.lastname: Tsujide
authors.affiliation: Clinical Research Coordination Department, Chugai Pharmaceutical Co., Ltd., Tokyo, Japan.
authors.forename: Yuzo
authors.initials: Y
authors.lastname: Nabeoka
authors.affiliation: Development Division, Mitsubishi Tanabe Pharma Corporation, Tokyo, Japan.
authors.forename: Takuya
authors.initials: T
authors.lastname: Sakuhiro
authors.affiliation: Clinical Evaluation Expert Committee, Drug Evaluation Committee, Japan Pharmaceutical Manufacturers Association, Tokyo, Japan.
authors.forename: Hiroshi
authors.initials: H
authors.lastname: Aoki
authors.affiliation: Administration Center for Clinical Trials Institute for Clinical Research, National Hospital Organization Osaka National Hospital, Osaka, Osaka, Japan.
authors.forename: Noriko
authors.initials: N
authors.lastname: Morishita
authors.affiliation: Center for Clinical Research, Hamamatsu University School of Medicine, Hamamatsu, Hamamatsu, Japan.
authors.forename: Chieko
authors.initials: C
authors.lastname: Suzuki
authors.affiliation: Center for Clinical Research, Hamamatsu University School of Medicine, Hamamatsu, Hamamatsu, Japan.
authors.forename: Shigeo
authors.initials: S
authors.lastname: Kachi
authors.affiliation: Office of Conformity Audit, Pharmaceuticals and Medical Devices Agency, Tokyo, Japan.
authors.forename: Emiko
authors.initials: E
authors.lastname: Kondo
authors.affiliation: Office of New Drug III (CNS/PNS/Anesthesia), Pharmaceuticals and Medical Devices Agency, Tokyo, Japan.
authors.forename: Yukiko
authors.initials: Y
authors.lastname: Komori
authors.affiliation: Keio Law School, Keio University, Tokyo, Japan.
authors.forename: Tetsu
authors.initials: T
authors.lastname: Isobe
authors.affiliation: Division of Clinical Pharmacology and Therapeutics, The Jikei University School of Medicine, Tokyo, Japan.
authors.forename: Shigeru
authors.initials: S
authors.lastname: Kageyama
authors.affiliation: Department of Clinical Pharmacology and Therapeutics, Hamamatsu University School of Medicine, Hamamatsu, Hamamatsu, Japan.
authors.forename: Hiroshi
authors.initials: H
authors.lastname: Watanabe
mesh_terms: D002986:Clinical Trials as Topic; D035881:Compensation and Redress; D004345:Drug Industry / Q000191:economics* / Q000941:ethics / Q000706:statistics & numerical data; D015507:Drugs, Investigational / Q000009:adverse effects; D064368:Healthy Volunteers / Q000331:legislation & jurisprudence*; D006801:Humans; D007345:Insurance Claim Review / Q000191:economics* / Q000941:ethics / Q000706:statistics & numerical data; D007564:Japan; D011795:Surveys and Questionnaires; D014947:Wounds and Injuries / Q000139:chemically induced / Q000191:economics*
chemical_list: D015507:Drugs, Investigational