Title: A Watershed Role of the Central Office of Investigator-initiated Clinical Trial in Cardiovascular Fields
Abstract: In the cardiovascular field, a variety of investigator-initiated clinical trials have been conducted in Japan. Investigator-initiated clinical trials in Japan are classified into two major categories; the trials under the Japanese Pharmaceutical Affairs Law (PAL) and the Ethical Guidelines for Clinical Studies (EGCS). The former trials called "Chiken" are conducted mainly by pharmaceutical and medical device manufacturers under a Clinical Trial Notification (CTN) equivalent to an IND (Investigational New Drug) in US. The quality of the trials of this category is known to be relatively high. Whereas, the quality varies among the latter trials under EGCS, and matters substantially because the management of the trials is not based on PAL. Most of the clinical trials conducted by investigators in Japan are classified as the latter trials. Moreover, even if the trials are successful, the results cannot lead us to the approval of new drug indications because the trials are not under a CTN. The progress of globalization in clinical trials proposes that the cardiovascular networks are able to perform the clinical trials based on ICH-GCP in Japan. Then, we have developed the investigator-initiated clinical trial under a CTN. Here, we report how we have developed and managed the investigator-initiated clinical trials based on PAL compared with the conventional trials under EGCS in Japan.
Publication Year: 2013
Publication Date: 2013-10-01
Language: en
Type: article
Indexed In: ['crossref']
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