title: Analysis of information submitted by clinical trial sponsors regarding the safety of investigational drugs.
abstract: During performance of clinical trials in medical institutions, information regarding the safety of investigational drugs is submitted by trial sponsors according to guidelines for good clinical practice. In the present study, reports of clinical trials conducted at the University of Tokyo Hospital were examined, focusing on the safety information provided to the Institutional Review Board (IRB). Two hundred two reports (52 protocols) of safety information were submitted to the IRB by clinical trial sponsors between April 2000 and March 2001, of which 185 contained a total of 3021 cases of adverse events. Of those, 194 reports were judged by clinical investigators/physicians not to be associated with any significant problems and the trials were continued. For 157 of those 194 reports, it was considered unnecessary to inform the test subjects of the report contents, including the adverse events. The decision of whether or not the test subjects should be informed of such contents tended to depend on the causal relationship between the adverse events and drug intake, as well as the predictability of the adverse events. For 8 of those 194 reports, the IRB recommended that the clinical investigators/ physicians provide information to the test subjects and/or submit detailed information on the status of these subjects to the IRB. From these results, we suggest that establishment of a system to unify and evaluate drug safety information is necessary to provide safe and efficient clinical trials.
authors.affiliation: Department of Pharmacy, The University of Tokyo Hospital, Faculty of Medicine, The University of Tokyo, Japan. risa-tky@umin.ac.jp
authors.forename: Risa
authors.initials: R
authors.lastname: Takayanagi
authors.forename: Yuko
authors.initials: Y
authors.lastname: Nakamura
authors.forename: Yuko
authors.initials: Y
authors.lastname: Nakajima
authors.forename: Akemi
authors.initials: A
authors.lastname: Shimizu
authors.forename: Hitoshi
authors.initials: H
authors.lastname: Nakamura
authors.forename: Yasuhiko
authors.initials: Y
authors.lastname: Yamada
authors.forename: Hiroshi
authors.initials: H
authors.lastname: Suzuki
authors.forename: Yoshihiro
authors.initials: Y
authors.lastname: Arakawa
authors.forename: Masao
authors.initials: M
authors.lastname: Omata
authors.forename: Tatsuji
authors.initials: T
authors.lastname: Iga
mesh_terms: D002986:Clinical Trials as Topic; D004346:Drug Information Services; D015507:Drugs, Investigational; D028744:Ethics Committees, Research; D006801:Humans; D012449:Safety
chemical_list: D015507:Drugs, Investigational