Analysis of the success rates of new drug development in Japan and the lag behind the US
Analysis of the success rates of new drug development in Japan and the lag behind the US
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DOI：
10.1016/j.healthpol.2011.11.008
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发表时间：
2012-03-01
期刊：
影响因子：
3.3
通讯作者：
Ono, Shunsuke
中科院分区：
文献类型：
--
作者：
Hirai, Yuka;Yamanaka, Yosuke;Ono, Shunsuke
目标：新药上市延迟一直是日本公众关注的主要问题。尽管人们认识到这种延迟是由工业研发行为和全球市场监管条件造成的，但造成这种严重延迟的具体机制尚不清楚。本研究分析了日本新分子实体临床开发项目的成功率与落后于美国的开发滞后之间的关系，为政策规划提供线索。方法：利用Cox比例风险模型估计临床开发的成功率与日本和美国的开发时差之间的关系。结果：日本的II期过渡成功率与落后于美国的开发滞后呈正相关。 III 期成功率的 Cox 回归分析结果与 II 期成功率结果相似，但不具有统计显着性。结论：滞后对后者国家（即日本）开发成功的有利影响似乎可以解释开发和上市的持续延迟。政府缩小新药获取差距的对策必须考虑这一机制以及对行业和目标人群的影响。 (C) 2011 Elsevier Ireland Ltd. 保留所有权利。
Objectives: The launch delay of new drugs has been a major public concern in Japan. Although it is recognized that the delay results from industrial R&D behaviors and regulatory conditions in the global market, the specific mechanisms underlying the significant delay have been unexplained. This study analyzed the association between the success rates of clinical development programs of new molecular entities in Japan and the development lag behind the US and provides clues for policy planning.Methods: The association between the success rates of clinical development and the development time lag between Japan and the US was estimated using the Cox proportional hazard model.Results: The phase II transition success rates in Japan were positively associated with the lags behind US development. Cox regression analysis results of phase III success rates were similar to phase II success rate results but were not statistically significant.Conclusions: The advantageous effect of lags on development success in the latter country (i.e., Japan) appears to explain the persistent delays in development and launch. The government's countermeasures to reduce the access gap of new drugs must consider this mechanism and the influence on both the industry and the target population. (C) 2011 Elsevier Ireland Ltd. All rights reserved.