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

  • Global Perspectives: Original Research
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Abstract

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.

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Authors and Affiliations

  1. Department of Drug Development & Regulatory Science, Keio University of Pharmacy, Tokyo, Japan

    Keitaro Nakajima PhD, Jun Urushidani, Tatsuo Kurokawa PhD & Koji Chiba PhD

  2. Regulatory Affairs Division, Development Japan, Pfizer Japan Inc, 3-22-7 Yoyogi, Shibuya-ku, Tokyo, 151-8589, Japan

    Keitaro Nakajima PhD

  3. Worldwide Safety and Regulatory, Pfizer Inc, Groton, CT, USA

    Ramzi Dagher MD

  4. Worldwide Safety and Regulatory, Pfizer Inc, San Diego, CA, USA

    Laurie Strawn PhD

  5. Laboratory of Clinical Pharmacology, Yokohama University of Pharmacy, Yokohama, Japan

    Koji Chiba PhD

Authors
  1. Keitaro Nakajima PhD
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  2. Ramzi Dagher MD
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  3. Laurie Strawn PhD
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  4. Jun Urushidani
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  5. Tatsuo Kurokawa PhD
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  6. Koji Chiba PhD
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Corresponding author

Correspondence to Keitaro Nakajima PhD.

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Nakajima, K., Dagher, R., Strawn, L. et al. The Relationship Between Development Start Lag and Approval Lag in Oncology Drug Development in Japan. Ther Innov Regul Sci 49, 911–919 (2015). https://doi.org/10.1177/2168479015579518

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  • DOI: https://doi.org/10.1177/2168479015579518

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