2020 Volume 57 Issue 2 Pages 96-100
International collaboration is an effective way of studying rare diseases such as childhood solid tumors. Currently, the solid tumor division of the Japan Children’s Cancer Group is working on three international collaborative clinical studies of liver tumors, extracranial germ cell tumors, and renal tumors. Data from these studies are managed by the data center of the National Center for Child Health and Development. However, some problems due to the differences in the contents of protocol between Japan and other countries, such as those in research implementation system, clinical data collection, and adverse event reporting, have been found. In particular, management of the qualification of participating institutions and researchers affiliated with the institution is strictly required in collaboration with the United States. Furthermore, some other problems exist, such as ensuring the expected patient number, collaborating with medical facilities for adults especially in cancers occurring in young adults, collection and provision of information in collaboration with overseas institutions, and difficulties due to the disparity between foreign rules and the Japanese Clinical Trials Act. There are still many challenges in supporting international collaborative studies including data management; therefore, we have to gain further experience and resolve problems found in the collaboration.
