Abstract
Twelve years have already passed since the investigator-initiated clinical trials were introduced in Japan. From the fact that there are drugs and medical devices were approved based on the results of investigator-initiated clinical trials, it is considered that the results of introducing investigator-initiated clinical trials were steadily obtained. During this time, Good Clinical Practice (GCP) was amended to facilitate execution of the investigator-initiated clinical trials. As a result, surrounding environment such as supporting system and research funding was dramatically changed. In addition, experiences of investigators, Clinical Research Coordinators (CRCs) and clinical trial sites were accumulated greatly. The phase Ⅰ clinical trials for the seeds that Academia developed came to be conducted and it is considered that the investigator-initiated clinical trials are proceeding to a new stage. This review describes the progress and future topic of the investigator-initiated clinical trials.
