Construction of an efficient transmission system for information on adverse events in clinical trials

Hiroyuki Furukawa, Masahiro Uchikata, Yukiko Matsushima, Sachie Osada, Eiko Yokoyama, Junko Ishizaki, Sakae Shimizu, Akira Kamiya, Ken ichi Miyamoto

Research output: Contribution to journalReview article

1 Citation (Scopus)

Abstract

The major problem in the management of information on adverse events is found in both the clinical trial sponsor and the trial institution. The primary cause is inconsistency in the sponsors and trial institutions due to the use of original management methods which differ among sponsors or among trial institutions. In order to solve this problem, it is proposed to classify adverse events into three groups: "Case Report A", "Case Report B" and "Accumulated Information" based on the detected place (Japan or foreign country), the detected phase (clinical trial or post-marketing), unknown or known event, and the degree of severity. "Case Report A" and "Case Report B" will be evaluated individually, and "Accumulated Information" will be evaluated collectively in the institutional review board. Electronic list data is provided to the trial institution as the standard version only, and individual alteration request to the list data from institutions should not be accepted. Therefore, each institution should arrange the list data for creating its own database, if needed. The list data is presently provided by electronic media which are currently used widely such as the floppy disk or CD-R etc, but it might be necessary to plan for use by electronic mail. By classifying the adverse events and using electronic data for providing information about adverse events, more efficient information management is expected in both sponsors and trial institutions.

Original languageEnglish
Pages (from-to)7-12
Number of pages6
JournalJapanese Journal of Clinical Pharmacology and Therapeutics
Volume34
Issue number1
DOIs
Publication statusPublished - 2003 Jan

Keywords

  • Adverse event
  • Clinical trial
  • Information technology
  • Transmission system

ASJC Scopus subject areas

  • Pharmacology
  • Pharmacology (medical)

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  • Cite this

    Furukawa, H., Uchikata, M., Matsushima, Y., Osada, S., Yokoyama, E., Ishizaki, J., Shimizu, S., Kamiya, A., & Miyamoto, K. I. (2003). Construction of an efficient transmission system for information on adverse events in clinical trials. Japanese Journal of Clinical Pharmacology and Therapeutics, 34(1), 7-12. https://doi.org/10.3999/jscpt.34.7