title: [Shared web-based data center for multi-institutional clinical trials: evaluation of UMIN-INDICE (university hospital medical information network-internet data and information center for medical research)in clinical trials of JIVROSG (Japan interventional radiology in oncology study group)].
abstract: A patient registration system is mandatory for establishing the scientific credibility of the multi-center clinical trials. The Japan Interventional Radiology in Oncology Study Group (JIVROSG) was organized in 2002 to establish evidence supporting the procedures used in interventional radiology. The Internet Data and Information Center for Medical Research (INDICE), provided by the University Hospital Medical Information Network(UMIN), has been utilized for patient registration in the clinical trials of JIVROSG. In this study, the safety and efficacy of UMIN-INDICE were evaluated. From 2002 to 2010, 18 clinical trials, including one international trial, were conducted. A total of 736 patients were enrolled from 51 institutions. No significant trouble was encountered during this period. A questionnaire survey demonstrated that 90% of participating researchers could use this system without difficulties. UMIN-INDICE may contribute to promoting clinical trials as an infrastructure of multicenter studies.
authors.affiliation: Iwate Medical University.
authors.forename: Miyuki
authors.initials: M
authors.lastname: Sone
authors.forename: Yasuaki
authors.initials: Y
authors.lastname: Arai
authors.forename: Takahiro
authors.initials: T
authors.lastname: Kiuchi
authors.forename: Hirono
authors.initials: H
authors.lastname: Ishikawa
authors.forename: Noriaki
authors.initials: N
authors.lastname: Aoki
authors.forename: Yoshitaka
authors.initials: Y
authors.lastname: Inaba
authors.forename: Tetsuya
authors.initials: T
authors.lastname: Yoshioka
authors.forename: Takeshi
authors.initials: T
authors.lastname: Aramaki
authors.forename: Takeshi
authors.initials: T
authors.lastname: Kobayashi
authors.forename: Toshiyuki
authors.initials: T
authors.lastname: Matsuoka
authors.forename: Hiroshi
authors.initials: H
authors.lastname: Anai
authors.forename: Noboru
authors.initials: N
authors.lastname: Tanigawa
authors.forename: Keigo
authors.initials: K
authors.lastname: Osuga
authors.forename: Yoshito
authors.initials: Y
authors.lastname: Takeuchi
authors.forename: Takushi
authors.initials: T
authors.lastname: Okusaka
authors.forename: Susumu
authors.initials: S
authors.lastname: Kanazawa
authors.forename: Osamu
authors.initials: O
authors.lastname: Matsui
authors.forename: Keigo
authors.initials: K
authors.lastname: Endo
mesh_terms: D002986:Clinical Trials as Topic; D006801:Humans; D020407:Internet; D011795:Surveys and Questionnaires