title: Serious adverse events and compensation in registration trials: a review of data from a Japanese university hospital.
abstract: BACKGROUND
  Clinical trials leading to regulatory approval, or registration trials, play a central role in the development of drugs and medical devices. The contribution of support staff, such as the clinical research coordinator (CRC) and administrative officers, in registration trials is now widely recognized. Attending to serious adverse events is an important duty of the CRC and investigators alike, and managing these complications and compensation constitutes a key responsibility. We retrospectively examined the frequency of serious adverse events and compensation events reported from 2007 through 2011 at Tokushima University Hospital, an academic hospital in rural Japan. We present herein the results of our analysis.
  
  
  RESULTS
  Over the five-year period, 284 subjects participating in 106 registration trials experienced a total of 43 serious adverse events, and eight compensation events were documented. Among the serious adverse events, 35 (81.4%) were considered not related to the investigational drug, and 17 (39.5%) resulted in withdrawal of the study drug. Patients with malignant diseases experienced serious adverse events significantly more frequently compared to those with non-malignant diseases (28.3% versus 8.2%, respectively; P < 0.01).
  
  
  CONCLUSIONS
  The CRC should be vigilant for serious adverse events in oncology clinical trials due to the generally higher frequency of these complications in subjects with malignancy. However, on an individual basis, the CRC may be seldom involved in the process for compensating serious adverse events. Therefore, the CRC's ability to share such experiences may serve as an opportunity for educating clinical trial support staff at the study site as well as those at other sites. However, further study is warranted to determine the role of the clinical trial support staff in optimizing methods for managing adverse events requiring compensation in registration trials.
authors.forename: Miho
authors.initials: M
authors.lastname: Watanabe
authors.forename: Soichiro
authors.initials: S
authors.lastname: Tajima
authors.forename: Rumi
authors.initials: R
authors.lastname: Katashima
authors.forename: Toshiko
authors.initials: T
authors.lastname: Miyamoto
authors.forename: Makiko
authors.initials: M
authors.lastname: Yamagami
authors.forename: Kazuo
authors.initials: K
authors.lastname: Minakuchi
authors.affiliation: Clinical Trial Center for Developmental Therapeutics, Tokushima University Hospital, Kuramoto-cho 2, Tokushima 770-8503, Japan. niseko@tokushima-u.ac.jp.
authors.forename: Hiroaki
authors.initials: H
authors.lastname: Yanagawa
mesh_terms: D002986:Clinical Trials as Topic; D035881:Compensation and Redress; D015507:Drugs, Investigational / Q000009:adverse effects*; D006780:Hospitals, Rural / Q000191:economics* / Q000941:ethics; D006785:Hospitals, University / Q000191:economics* / Q000941:ethics; D006801:Humans; D007564:Japan; D009369:Neoplasms / Q000188:drug therapy* / Q000473:pathology; D056737:Safety-Based Drug Withdrawals
chemical_list: D015507:Drugs, Investigational
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