2014 Fiscal Year Final Research Report
Establishment of the optimal operations in the molecularly targeted drug approvals
| Project/Area Number |
25670240
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| Research Category |
Grant-in-Aid for Challenging Exploratory Research
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| Allocation Type | Multi-year Fund |
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| Research Field |
Medical sociology
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| Research Institution | Yamagata University |
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Principal Investigator |
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| Co-Investigator(Kenkyū-buntansha) |
NARIMATSU Hiroto 山形大学, 医学部公衆衛生学講座, 准教授 (50524419)
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| Co-Investigator(Renkei-kenkyūsha) |
SASAHARA Yuriko 山形大学, 医学部臨床腫瘍学講座, 医員 (90592189)
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| Project Period (FY) |
2013-04-01 – 2015-03-31
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| Keywords | レギュラトリーサイエンス / 分子標的薬 / クリティカルレビュー |
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| Outline of Final Research Achievements |
We extracted molecularly targeted drugs listed in the Medical Formulary 2013. For the 21 identified drugs, 32 published Pharmaceuticals and Medical Devices Agency (PMDA) reports were open to the public. Data regarding clinical trials were extracted from the published PMDA reports, and were assessed to clarify the characteristic examinations required for the approval of molecularly targeted drugs. Extensive evidence was not needed for molecularly targeted drugs. Molecularly targeted drugs approved by the PMDA have flexible approval in terms of safety and efficacy.
We reported in the journal that details the process of decision making with respect to whether a patient receives targeted therapy. Moreover, we conducted a questionnaire survey on the satisfaction about cost, effectiveness, and toxicity of molecular target drugs. Of 250 doctors, 144 answered the questions; it was revealed that they did not have the excessive favorable expectations for molecularly targeted drugs.
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| Free Research Field |
臨床腫瘍学
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