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[日本Scrum的现状与未来展望]

[Current Status and Future Perspectives of SCRUM-Japan].

作者信息

Ohtsu Atsushi, Goto Koichi, Yoshino Takayuki, Okamoto Wataru, Tsuchihara Katsuya

机构信息

National Cancer Center Hospital East.

出版信息

Gan To Kagaku Ryoho. 2017 Aug;44(8):621-626.

Abstract

SCRUM-Japan was launched as a nation-wide genome screening consortium for recruiting patients to 35 sponsor-/investigator- initiated registration trials in collaboration with 15 pharmaceutical companies and 240 hospitals. During the first period between February 2015 and March 2017, a total of 4,805 patients have been enrolled. Genomic profiling of each cancer were analyzed and newdrug applications of label expansion are in preparation based on the results of several registration studies including investigator-initiated trial of vandetanib for RET fusion gene positive non-small cell lung cancer. In addition, on-time clinical-genome data sharing with industries and academic institutions and prospective cohort registry for new drug evaluation as a historical control data have already initiated, which will facilitate new agent development in Japan. In the second period started from April 2017, new studies using cutting-edge liquid biopsy and immune-genome panel for precision medi- cine will start soon. These efforts are attempted towards a leading group for innovative clinical/translations researches in the world.

摘要

SCRUM-日本作为一个全国性的基因组筛查联盟启动,旨在与15家制药公司和240家医院合作,招募患者参与35项由申办方/研究者发起的注册试验。在2015年2月至2017年3月的第一阶段,共有4805名患者入组。对每种癌症进行了基因组分析,并根据包括研究者发起的凡德他尼治疗RET融合基因阳性非小细胞肺癌试验在内的多项注册研究结果,准备进行标签扩展的新药申请。此外,已经开始与行业和学术机构进行及时的临床基因组数据共享,并建立前瞻性队列登记作为新药评估的历史对照数据,这将促进日本新型药物的开发。从2017年4月开始的第二阶段,将很快启动使用前沿液体活检和免疫基因组检测板进行精准医学的新研究。这些努力旨在成为世界创新临床/转化研究的领先团队。

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