CRCが現実に直面している問題点

全国243施設におけるCRCアンケート調査の結果から

抄録

Clinical research coordinators (CRC) are now considered to be indispensable specialists in performing clinical trials, though CRC as a medical profession was only recently introduced to Japan. As the situation of clinical trials in Japan is different from that overseas such as in the United States, where the CRC system was originally developed, Japanese CRCs may face a different set of problems than those overseas. It is necessary precisely understand the present status of CRCs and the problems in establishing an educational program. Thus, we surveyed the status and problems of Japanese CRCs by a questionnaire. The question-naires were sent to 243 institutes, which are known to conduct clinical trials, and 215 replies were collected from 84 institutes. Approximately 60% of CRCs work full time, and the rest have an additional position. Their medical education backgrounds were: pharmacists (43%), nurses (38%), medical technicians (13%) and other bachelor degrees. While experience as CRC itself is short, most CRCs have a long experience in their own medical field. More than 80% of CRCs assist doctors in gaining informed consent. CRCs are faced a variety of difficulties in daily practice, and the difficulties differ, depending on their own medical background. Accordingly, several types of optional courses should be recommended for developing CRC educational programs in Japan.