INVESTIGATOR-INITIATED CLINICAL TRIALS FOR NEW DRUGS IN JAPAN: CHALLENGES AND PERSPECTIVES

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Abstract

International clinical trials for new drugs have been commonly conducted in Asian countries. However, most of the trials are pharmaceutical company-sponsored studies. Investigator-initiated clinical trials for new drugs are important for avoiding biases by commercialism, keeping investigator's activities and motivation, and providing evidences for rare tumors.

GOG Japan is a clinical trial group for international member of Gynecologic Oncologic Group in the United States, and founded under umbrella of NPO NPO Japanese Gynecologic Oncology Group (JGOG) in 2002. We have registered a total of 331 patients for 11 of the GOG trials until 2011. GOG-218, that is a phase III trial of bevacizumab for advanced ovarian cancer, is the first investigator-initiated, indication-directed international trial in Japan. The bevacizumab was provided from NCI. The study demonstrated the benefit in terms of progression-free survival, and we are preparing the application for ovarian cancer to the regulatory authority in Japan. We are launching a new investigator-initiated clinical trial of temsirolimus for ovarian cancer with GOG.

To manage investigator-initiated clinical trials for new drugs successfully, the ICH-GCP should be followed and organize the infrastructure of clinical trial operation system including the statistical datacenter and clinical research coordinators into academic facilities. Moreover, a collaboration with Asian countries and investigators is essential for activation of investigator-initiated clinical trials and will provide benefits for Asian cancer patients.

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