日本的瘤药物滞后:在过去十年中是否有所改善?
Yoshifumi Tachibana1,2, Mamoru Narukawa3
1Department of Clinical Medicine (Pharmaceutical Medicine), Graduate School of Pharmaceutical Sciences, Kitasato University, 5-9-1 Shirokane, Minato-Ku, Tokyo, 108-8641, Japan. tachibana.yoshifumi@st.kitasato-u.ac.jp.
International journal of clinical oncology
|August 10, 2023
概括
日本和美国之间抗癌药物的药物滞后没有减少,未经批准的药物显著影响了时间表. 日本 日本 日本 日本 日本.
科学领域:
- 制药研发领域的研究和开发.
- 全球药物监管事务全球药物监管事务
- 瘤学药物获取方法
背景情况:
- 在抗癌药物方面,日本和美国之间的药物滞后一直是一个持续的问题.
- 虽然一些研究表明这种情况有所下降,但在日本,更多的药物仍未获得批准.
- 量化未经批准的药物对这种差距的影响至关重要.
研究的目的:
- 量化未经批准的抗癌药物对日本和美国之间药物滞后的影响.
- 分析十年来药物批准滞后的趋势.
- 确定影响药物批准时间表的因素.
主要方法:
- 在美国 (2011-2022) 批准的136种抗癌药物的分析.
- 使用Kaplan-Meier方法计算中位批准滞后,将未经批准的药物作为受审查的数据来处理.
- 考克斯回归分析,以探索与批准滞后相关的因素.
主要成果:
- 批准延迟的中位数从961天 (2011-2016) 增加到1547天 (2017-2022).
- 日本参与全球关键试验与较短的批准滞后相关.
- 较小的非日本公司 (全球前20大销售额之外) 的申请显示较长的滞后.
结论:
- 药物滞后在过去十年中并没有减少;它已经恶化.
- 增加日本在关键试验中的参与是必要的,但不足.
- 建议制定一项计划,鼓励小型非日本公司将日本纳入全球发展.
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