| Project/Area Number |
18K06779
|
|---|
| Research Category |
Grant-in-Aid for Scientific Research (C)
|
| Allocation Type | Multi-year Fund |
|---|
| Section | 一般 |
|---|
| Review Section |
Basic Section 47060:Clinical pharmacy-related
|
|---|
| Research Institution | Kyoto University (2021-2023)
The University of Tokyo (2018-2020) |
|---|
Principal Investigator |
|
|---|
| Project Period (FY) |
2018-04-01 – 2024-03-31
|
| Project Status |
Completed (Fiscal Year 2023)
|
| Budget Amount *help |
¥4,420,000 (Direct Cost: ¥3,400,000、Indirect Cost: ¥1,020,000)
Fiscal Year 2020: ¥1,690,000 (Direct Cost: ¥1,300,000、Indirect Cost: ¥390,000)
Fiscal Year 2019: ¥1,300,000 (Direct Cost: ¥1,000,000、Indirect Cost: ¥300,000)
Fiscal Year 2018: ¥1,430,000 (Direct Cost: ¥1,100,000、Indirect Cost: ¥330,000)
|
|---|
| Keywords | 抗癌剤 / 薬事規制 / 薬事承認 |
|---|
| Outline of Final Research Achievements |
In the US, the FDA issued a draft guidance in March 2023, suggesting that the FDA will operate more conservatively than in the past regarding accelerated approval based solely on single-arm study results. On the other hand, for hematologic malignancies, in which the number of patients is relatively small, whether or not regulatory approval is granted based on a single-arm, phase 2 study will have a significant impact on the timing of approval in each country. The study revealed a trend that the approval timing of drugs approved in the US for hematological malignancies based on the results of phase 2 trials tends to be delayed in Japan because Japan did not participate in the phase 2 trials.
|
| Academic Significance and Societal Importance of the Research Achievements |
米国では早期臨床試験結果に基づいて迅速承認取得された抗癌剤が毒性等の問題で市販後の比較試験で既存の標準治療と比較した優越性が示されないという事例が出てきたことを受けて、迅速承認制度の運用をより厳格に行う傾向が見えてきている。その一方で、日本では、本研究成果により、日本で臨床試験による開発が遅れることにより、米国で承認された薬剤が遅れて承認される傾向が明らかとなった。本研究成果により今後日本で承認が遅れた薬剤の特徴をより詳細に解析できるため、本研究成果は臨床的有用性が真に高いと言える薬剤を日本で早期に承認するためにどのように条件付き承認制度を運用すればよいかを議論する上での重要な基礎資料となる。
|
