title: [Roles of nurses in clinical trials of anticancer drug development].
abstract: In Japan nurses were not much involved in clinical trials in connection with new drug development in the field of cancer nursing in the past for the following reasons: 1) systems for cooperations among different services in hospital were not well established. 2) There was a lack of information about the drugs from physicians, 3) It was difficult to obtain informed consent from patients. In the new GCP system of Japan started last April in accordance with ICH-GCP, persons who support patients and assist physician investigators are desperately needed to maintain QA and QC of the clinical trials. Research nurses are the most suitable persons to fulfill such positions. The roles of research nurses in these settings are patient care, coordinator, data collecting and educator in the new system.
authors.affiliation: Dept. of Nursing, Cancer Institute Hospital, Japanese Foundation for Cancer Research.
authors.forename: C
authors.initials: C
authors.lastname: Matsuura
mesh_terms: D000970:Antineoplastic Agents; D002986:Clinical Trials as Topic; D017277:Drug Approval; D004506:Education, Nursing; D006801:Humans; D009726:Nurses / Q000592:standards*; D011786:Quality Control