Application of the SCRUM-Japan Registry for Oncology Agent Development

Abstract

SCRUM-Japan was launched as a nation-wide genome screening consortium for recruiting lung/gastrointestinal cancer patients to 40 sponsor-/investigator-initiated registration trials in collaboration with 15 pharmaceutical companies and 245 hospitals. During the first period between February 2015 and March 2017, a total of 4,800 patients have been enrolled. Genomic profiling of each cancer were analyzed and new drug applications for label expansion are in preparation based on the results of several registration studies. In addition, on-time clinical-genome data sharing with industries and academic institutions and registry study for new drug evaluation as a historical control data have already initiated, which will facilitate new agent development in Japan. In the registry study, three approaches are indicated for the purpose of historical control data at a new agent evaluation in regulatory authorities: retrospective data of the patients enrolled for completed registration study, prospective registry data collection for orphan-fractionated population, and parallel data collection along with new investigator-initiated registration study. With the outcome data of both developmental studies and registry, establishment of precision medicine in Japan is anticipated.