title: [Documents for clinical trials of new drugs: results of their reviews prior to submissions to IRB].
abstract: A prior review process was introduced in the Institutional Review Board (IRB) of the University of Tokyo Hospital to facilitate the evaluation of clinical trial plans for new drugs. This study summarizes the results of prior reviews of 73 protocols that were submitted to the IRB during 1999-2000. A total of 955 items were taken up for discussion at the prior review. Among them, 325 (34.0%) were related to the profile/description of investigational drugs themselves, and 252 (26.4%) were related to the trial plan. Major requests related to investigational drugs and given to applicants after the prior review were on adverse reactions, pharmacodynamics, and pharmacokinetics. Items related to patient selection criteria and usage of concomitant drugs were major requests related to the protocol. In some cases, protocols were amended by applications in accordance with the requests. The study shows that the review of new drug clinical trial plans prior to the evaluation by the IRB and examination from a pharmaceutical viewpoint are meaningful and worthwhile.
authors.affiliation: Department of Pharmacy, University of Tokyo Hospital, Faculty of Medicine, University of Tokyo, 7-3-1 Hongo, Bunkyo-ku, Tokyo 113-8655, Japan. risa-tky@umin.ac.jp
authors.forename: Risa
authors.initials: R
authors.lastname: Takayanagi
authors.forename: Yasuhiko
authors.initials: Y
authors.lastname: Yamada
authors.forename: Kaori
authors.initials: K
authors.lastname: Watanabe
authors.forename: Hitoshi
authors.initials: H
authors.lastname: Nakamura
authors.forename: Masao
authors.initials: M
authors.lastname: Omata
authors.forename: Tatsuji
authors.initials: T
authors.lastname: Iga
mesh_terms: D026661:Clinical Trials Data Monitoring Committees; D002986:Clinical Trials as Topic; D028744:Ethics Committees, Research; D006801:Humans