2016 Fiscal Year Final Research Report
Study on the factor influencing oncologic drugs approval review time between Japan and US.
| Project/Area Number |
26350560
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| Research Category |
Grant-in-Aid for Scientific Research (C)
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| Allocation Type | Multi-year Fund |
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| Section | 一般 |
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| Research Field |
Medical engineering assessment
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| Research Institution | The University of Tokyo |
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Principal Investigator |
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| Project Period (FY) |
2014-04-01 – 2017-03-31
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| Keywords | 抗がん剤 / 医薬品開発 / 日米 / 承認 |
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| Outline of Final Research Achievements |
Various factors have reported as the cause of oncologic drug lag. Review time of Pharmaceuticals and Medical Devices Agency in Japan has become almost as same as that of U.S. Food and Drug Administration. However, drug lag is still shown. To study on the cause of drug lag between Japan and U.S., 41 oncologic drugs approved between 2001 and 2014 in both countries were analyzed. Drug lag of drugs approved between 2001 and 2010 is 57 months (mean), and that after 2011 was 9 months. Factors including guidance for treatment were analyzed, and most influenced factor is the kind of pivotal studies. In seven drugs out of eight drugs, pivotal studies were conducted as multinational studies. To achieve earlier approval, participation into multinational clinical trials is considered the most important factor.
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| Free Research Field |
レギュラトリーサイエンス
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