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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| Project Status |
Completed (Fiscal Year 2016)
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| Budget Amount *help |
¥3,250,000 (Direct Cost: ¥2,500,000、Indirect Cost: ¥750,000)
Fiscal Year 2016: ¥780,000 (Direct Cost: ¥600,000、Indirect Cost: ¥180,000)
Fiscal Year 2015: ¥910,000 (Direct Cost: ¥700,000、Indirect Cost: ¥210,000)
Fiscal Year 2014: ¥1,560,000 (Direct Cost: ¥1,200,000、Indirect Cost: ¥360,000)
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| Keywords | 抗がん剤 / 医薬品開発 / 日米 / 承認 / レギュラトリーサイエンス / 承認審査 / 開発環境 |
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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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Report
(4 results)
Research Products
(20 results)
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[Journal Article] he effects of bolus supplementation of branched-chain amino acids on skeletal muscle mass, strength, and function in patients with rheumatic disorders during glucocorticoid treatment.2016
Author(s)
Yoshikawa N, Shimizu N, Uehara M, Oda A, Matsumiya R, Matsubara E, Kobayashi H, Hosono O, Kuribara-Souta A, Baba H, Nagamura F, Kiryu S, Tanaka H.
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Journal Title
Mod Rheumatol.
Volume: 28
Pages: 1-10
Related Report
Peer Reviewed
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[Journal Article] Effect of graft sources on allogeneic hematopoietic stem cell transplantation outcome in adults with chronic myeloid leukemia in the era of tyrosine kinase inhibitors: a Japanese Society of Hematopoietic Cell Transplantation retrospective analysis.2014
Author(s)
Ohashi K, Nagamura-Inoue T, Nagamura F, Tojo A, Miyamura K, Mori T, Kurokawa M, Taniguchi S, Ishikawa J, Morishima Y, Atsuta Y, Sakamaki H.
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Journal Title
Int J Hematol
Volume: 100
Issue: 3
Pages: 296-306
DOI
Related Report
Peer Reviewed / Open Access
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