− Standardization and Collaboration among Japanese Cancer Trial Groups − Japanese Cancer Trial Network

Japanese Cancer Trial Network

Japanese Cancer Trial Network (JCTN) is a voluntary consortium consisting of nine major cancer cooperative groups in Japan. There is no oversight authority which supervises the activities of investigator-initiated clinical trial groups in Japan; thus, the standardization of study implementing methods had been required for a long time. The mission of JCTN is the standardization of study process which enables us to improve the ethical and scientific quality of Japanese investigator-initiated clinical trials. Collaboration among Japanese clinical trial groups is another important mission of JCTN.

JCTN was organized in 2014. The networking is supported in part by the National Cancer Center Research and Development Fund (26-A-22,29-A-15,2020-A-13). The following nine clinical trial groups are the current member groups of JCTN.

JCTN has issued three common guidelines in 2015: (i) central monitoring, (ii) site visit audit and (iii) adverse events reporting.

These guidelines were revised in 2019, and are compliant with ICH-GCP, and Japanese Ethical Guideline of Medical Research for Human Subjects, and the Clinical Trials Act. They are expected to be utilized as the standard for Japanese investigator-initiated clinical trials.

In addition to these guidelines, JCTN member groups have shared the information about various aspects of clinical trials. The headquarter members of JCTN hold a periodic meeting to discuss about practical issues of trial management. The investigators from several Japanese clinical trial groups have shared their study concepts and facilitate intergroup studies in lung and gastrointestinal area.

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