An Empirical Analysis of Japan's Drug Development Lag Behind the United States
An Empirical Analysis of Japan's Drug Development Lag Behind the United States
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日本药品研发落后于美国的实证分析
DOI：
10.1002/jcph.2023
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发表时间：
2022
期刊：
影响因子：
--
通讯作者：
Suzuki Takeshi
中科院分区：
文献类型：
--
作者：
Nakamura Hiroshi;Wakutsu Naohiko;Murayama Satoshi;Suzuki Takeshi
“药物滞后”（即新药审批滞后）阻碍了患者获得创新新药。从2000年代末到2010年代初，药物滞后在日本引起了激烈的争论。它由“开发滞后”（即新药申请的提交日期滞后）和“审评滞后”（即审评周期的差异）组成。由于这两种滞后有不同的原因，并且在日本显示出明显不同的近期趋势，我们重点关注日本和美国之间的开发滞后-与大多数以前的文献相反-基于我们使用公开数据源为2008年至2018年的所有新药创建的数据库。首先，我们发现日本相对于美国的发展滞后并没有从总体分布上缩小，而不是从以往研究的中心点--中间值上缩小。第二，对影响开发滞后的因素（产品特性）进行了研究，发现在美国进行多地区临床试验的产品和被认定为“突破性疗法”的产品，开发滞后显著缩短，稳健性高，而价格溢价的产品则不然。最后，我们讨论了这些结果的政策含义。例如，对于被认为会获得价格溢价的创新新药，需要从临床试验的初始阶段就加强对早期申请的政策支持。还必须促进外国审查机关评价方面的信息共享，以便在本国得到有效利用。
The “drug lag” (ie, the approval lag for new drugs) hinders patients’ access to innovative new medicines. The drug lag was heavily debated in Japan from the late 2000s to the early 2010s. It consists of “development lag” (ie, the submission date lag for new drug applications) and “review lag” (ie, the difference in review periods). As the 2 lags have different causes and display significantly different recent trends in Japan, we focus on the development lag—in contrast with most previous literature—between Japan and the United States, based on a database we created for all new drugs from 2008 to 2018 using publicly available data sources. First, we found that Japan's development lag relative to the United States did not shrink in terms of the overall distribution rather than the median, which was the focus of most prior studies. Second, we examined the factors (product characteristics) that significantly affected the development lag and found that products that underwent multiregional clinical trials and those that were certified as “breakthrough therapies” in the United States had significantly shorter development lags with high robustness, whereas products receiving price premiums did not. Finally, we discussed the policy implications of these results. For instance, innovative new drugs that are presumed to receive price premiums require enhanced policy support for early application from the initial stages of clinical trials. It is also essential to promote information sharing regarding evaluations by foreign reviewing authorities for efficient use in the home country.
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影响因子：
56.9
作者：
S. Peltzman;H. Wiener
通讯作者：
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影响因子：
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作者：
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发表时间：
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影响因子：
2
作者：
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通讯作者：
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影响因子：
3.4
作者：
Nakayama, Hiroki;Matsumaru, Naoki;Tsukamoto, Katsura
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Tsukamoto, Katsura