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Background <p>This study aimed to examine the characteristics of First-in-human (FIH) trials conducted in Japan and the US and whether the probability of approval for pharmaceuticals that had undergone FIH trials differs in the two countries.</p> Methods <p>FIH trials of anticancer drugs initiated between 2007 and 2017 were investigated in this study. The trials were searched using ClinicalTrials.gov.</p> Results <p>There were 22 FIH trials conducted in Japan and 261 in the US. Of these, six drugs (27.2%) were approved in Japan and 27 (10.3%) were approved in the US, indicating that the probability of approval was significantly higher for FIH trials conducted in Japan than in the US. Comparison of the characteristics of FIH trials between Japan and the US, showed that 81.8% of the FIH trials conducted in Japan were sponsored by the top 20 pharmaceutical companies, whereas 55.6% in the US were sponsored by non-top 20 companies (<i>P</i> = <i>0</i>.003, Chi-square test). The number of patients was higher in Japan than in the US (<i>P</i> = <i>0</i>.044). Further, all of the trials conducted in Japan were multiregional clinical trials in collaboration with other countries such as Europe and the US, whereas 49.0% of the trials in the US were conducted in the US alone (<i>P</i> &lt; <i>0</i>.001).</p> Conclusion <p>We inferred that the FIH trials conducted in Japan are multiregional clinical trials by major pharmaceutical companies with Europe and the US, and are conducted with drugs that are expected to have a high probability of successful approval.</p>

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A cross-sectional study on the first-in-human trials of anticancer drugs in Japan and the United States and the probability of approval

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  • 发表日期：

    2025年8月6日

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  • Akari Mukaida,
  • Hideki Maeda

摘要

Background

This study aimed to examine the characteristics of First-in-human (FIH) trials conducted in Japan and the US and whether the probability of approval for pharmaceuticals that had undergone FIH trials differs in the two countries.

Methods

FIH trials of anticancer drugs initiated between 2007 and 2017 were investigated in this study. The trials were searched using ClinicalTrials.gov.

Results

There were 22 FIH trials conducted in Japan and 261 in the US. Of these, six drugs (27.2%) were approved in Japan and 27 (10.3%) were approved in the US, indicating that the probability of approval was significantly higher for FIH trials conducted in Japan than in the US. Comparison of the characteristics of FIH trials between Japan and the US, showed that 81.8% of the FIH trials conducted in Japan were sponsored by the top 20 pharmaceutical companies, whereas 55.6% in the US were sponsored by non-top 20 companies (P = 0.003, Chi-square test). The number of patients was higher in Japan than in the US (P = 0.044). Further, all of the trials conducted in Japan were multiregional clinical trials in collaboration with other countries such as Europe and the US, whereas 49.0% of the trials in the US were conducted in the US alone (P < 0.001).

Conclusion

We inferred that the FIH trials conducted in Japan are multiregional clinical trials by major pharmaceutical companies with Europe and the US, and are conducted with drugs that are expected to have a high probability of successful approval.