The Relationship Between Development Start Lag and Approval Lag in Oncology Drug Development in Japan

Keitaro Nakajima, Ramzi Dagher, Laurie Strawn, Jun Urushidani, Tatsuo Kurokawa, Koji Chiba

研究成果: Article査読

6 被引用数 (Scopus)

抄録

Background: The delay of initiation of clinical development is considered a causes of delay of approval of drugs (drug lag) in Japan. Methods: 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. Results: 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). Conclusions: 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.

本文言語English
ページ(範囲)911-919
ページ数9
ジャーナルTherapeutic Innovation and Regulatory Science
49
6
DOI
出版ステータスPublished - 2015 11月 1

ASJC Scopus subject areas

  • 薬理学、毒性学および薬学(その他)
  • 公衆衛生学、環境および労働衛生
  • 薬理学(医学)

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