title: Problems with registration-directed clinical trials for lung cancer in Japan.
abstract: New anticancer agents against lung cancer are needed because efficacy of chemotherapy is limited. The long time required, low quality, and considerable costs of registration-directed clinical trials in Japan ("Chiken") have been pointed out. The quality of 24 phase I and 41 phase II trials of an anticancer drug for lung cancer were analyzed according to the approval year of the drug. The human resources and infrastructure to support oncology clinical practice and clinical trials were compared between Japan and the USA. A maximum tolerated dose was not defined in any of seven phase I trials before 1989, and was determined in two of six trials between 1989 and 1996 and in seven of 10 trials thereafter. Before 1989, 29 (20%) of 142 patients registered in two trials were ineligible, and the number of ineligible patients was not reported in the five trials. Sample size calculations were not performed in any of seven phase II trials before 1989 and were performed in only four of 10 trials between 1989 and 1996 and in all 23 trials conducted thereafter. The shortage of human resources, including medical oncologists, oncology nurse practitioners and clinical research coordinators, is serious and acute. The infrastructure to support clinical trials also remains insufficient in Japan. In conclusion, registration-directed clinical trials of anticancer agents have advanced significantly during last three decades but remain unsatisfactory. The development of infrastructure and human resources is an urgent task to ensure high-quality clinical trials without unnecessary delays.
authors.affiliation: Division of Internal Medicine and Thoracic Oncology, National Cancer Center Hospitalm Tsukiji 5-1-1, Chuo-ku, Tokyo 104-0045, Japan. isekine@ncc.go.jp
authors.forename: Ikuo
authors.initials: I
authors.lastname: Sekine
authors.forename: Hiroshi
authors.initials: H
authors.lastname: Nokihara
authors.forename: Noboru
authors.initials: N
authors.lastname: Yamamoto
authors.forename: Hideo
authors.initials: H
authors.lastname: Kunitoh
authors.forename: Yuichiro
authors.initials: Y
authors.lastname: Ohe
authors.forename: Nagahiro
authors.initials: N
authors.lastname: Saijo
authors.forename: Tomohide
authors.initials: T
authors.lastname: Tamura
mesh_terms: D000970:Antineoplastic Agents / Q000627:therapeutic use*; D002986:Clinical Trials as Topic / Q000592:standards*; D017321:Clinical Trials, Phase I as Topic; D017322:Clinical Trials, Phase II as Topic; D006801:Humans; D007564:Japan; D008175:Lung Neoplasms / Q000188:drug therapy*; D012042:Registries