Nakajima Keitaro, Dagher Ramzi, Strawn Laurie, Urushidani Jun, Kurokawa Tatsuo, Chiba Koji
1 Department of Drug Development & Regulatory Science, Keio University of Pharmacy, Tokyo, Japan.
2 Regulatory Affairs Division, Development Japan, Pfizer Japan Inc, Tokyo, Japan.
Ther Innov Regul Sci. 2015 Nov;49(6):911-919. doi: 10.1177/2168479015579518.
The delay of initiation of clinical development is considered a causes of delay of approval of drugs (drug lag) in Japan.
For oncology drugs newly approved between 2000 and 2012 in Japan, a possible impact of delay of initiation of clinical development (development start lag [DSL]) on delay of approval (approval lag [AL]) was investigated, focusing on the delay from the US timelines. The equation defining the relationship between the DSL and AL of 33 oncology drugs was calculated by using simulation models, then the Pearson coefficient of correlation between parameters was calculated.
From the analysis of all drugs investigated, a positive relationship between the DSL and AL was suggested. However, the relationship seemed to have 2 phases, including a flat phase, followed by a linearly increased phase with a breakpoint at 2340 DSL days (approximately 6.4 DSL years).
Shortening the DSL is important for reducing large AL, but it is not necessary to eliminate the DSL completely for the purpose of minimizing the AL.
临床开发启动的延迟被认为是日本药物批准延迟（药物滞后）的一个原因。
对于2000年至2012年在日本新批准的肿瘤药物，研究了临床开发启动延迟（开发启动滞后[DSL]）对批准延迟（批准滞后[AL]）的可能影响，重点关注与美国时间线相比的延迟情况。通过使用模拟模型计算了33种肿瘤药物的DSL和AL之间关系的方程，然后计算了参数之间的皮尔逊相关系数。
从对所有研究药物的分析来看，DSL和AL之间存在正相关关系。然而，这种关系似乎有两个阶段，包括一个平稳阶段，随后是一个线性增长阶段，在DSL为2340天（约6.4个DSL年）时有一个断点。
缩短DSL对于减少较大的AL很重要，但为了使AL最小化而完全消除DSL并非必要。
