SY4-4 - Performing Phase I Clinical Trials of Investigational Anticancer Agents in a University Hospital in Japan: The Current Status and Problems for the Future

Abstract

ABSTRACT The Department of Clinical Oncology and Chemotherapy, Nagoya University Hospital, established in 2005, is a clinical department that consists of eight full-time physicians including five Board-Certified medical oncologists with one full-time licensed nurse. The department performs outpatient chemotherapy for cancers that occur in all organs and is regularly consulted by other clinical departments on matters related to chemotherapy and palliative care. As a result of the enthusiasm for early-phase clinical trials of anticancer agents under development, the department has been entrusted with a total of 12 industry-sponsored clinical trials for registration so far, of which 4 were international joint studies and 9 were those investigating agents that had never been administered in Japanese subjects. As of January 2012, 77 received the investigational agents among 90 subjects who gave written informed consent for the participation in clinical trials. We enrolled the subjects with cancers that occur in a variety of organs, reflecting close collaboration with each of the other clinical departments. In cooperation with a few clinical research coordinators (CRC) who belong to the hospital and who are in charge of each trial, the nurse belonging to the department plays important roles especially in the evaluation of adverse events and in the sample handlings of pharmacokinetic study or biomarker analysis, which are crucial for phase I trials. The experts in fields other than medical oncology in the hospital frequently participate in the trials, especially in those that investigate molecular targeting agents, for the evaluation and management of adverse events that generally demand detailed knowledge and skills. Therefore, because phase I trials require high-level specialization, important problems for the future will include building and maintaining a dedicated system with a team approach focusing on phase I trials of investigational anticancer agents.