Characteristics of Multi-Regional Clinical Trials Conducted in Asia, Focusing on Japan's Participation and Small/Medium Companies-Sponsored Trials

doi:10.1007/s43441-025-00837-4

. 2025 Jul 16.

doi: 10.1007/s43441-025-00837-4. Online ahead of print.

Characteristics of Multi-Regional Clinical Trials Conducted in Asia, Focusing on Japan's Participation and Small/Medium Companies-Sponsored Trials

Akihito Kojima^{1

2}, Hideki Hanaoka^{1

3}, Yoshiaki Uyama^{4

5

6

7}

Affiliations

¹ Department of Regulatory Science of Medicine, Graduate School of Medicine, Chiba University, Chiba, Japan.
² Regulatory Management Operation Department, Daiichi Sankyo Co., Ltd, Tokyo, Japan.
³ Division of Clinical Research Center, Chiba University Hospital, Chiba, Japan.
⁴ Department of Regulatory Science of Medicine, Graduate School of Medicine, Chiba University, Chiba, Japan. uyama-yoshiaki@pmda.go.jp.
⁵ Center for Regulatory Science, Pharmaceuticals and Medical Devices Agency, Kasumigaseki 3-3-2, Chiyoda-ku, Tokyo, 100-0013, Japan. uyama-yoshiaki@pmda.go.jp.
⁶ Graduate School of Medicine, Nagoya University, Nagoya, Japan. uyama-yoshiaki@pmda.go.jp.
⁷ Graduate School of Pharmaceutical Sciences, Nagoya City University, Nagoya, Japan. uyama-yoshiaki@pmda.go.jp.

PMID: 40670856
DOI: 10.1007/s43441-025-00837-4

Characteristics of Multi-Regional Clinical Trials Conducted in Asia, Focusing on Japan's Participation and Small/Medium Companies-Sponsored Trials

Akihito Kojima et al. Ther Innov Regul Sci. 2025.

. 2025 Jul 16.

doi: 10.1007/s43441-025-00837-4. Online ahead of print.

Authors

Akihito Kojima^{1

2}, Hideki Hanaoka^{1

3}, Yoshiaki Uyama^{4

5

6

7}

Affiliations

¹ Department of Regulatory Science of Medicine, Graduate School of Medicine, Chiba University, Chiba, Japan.
² Regulatory Management Operation Department, Daiichi Sankyo Co., Ltd, Tokyo, Japan.
³ Division of Clinical Research Center, Chiba University Hospital, Chiba, Japan.
⁴ Department of Regulatory Science of Medicine, Graduate School of Medicine, Chiba University, Chiba, Japan. uyama-yoshiaki@pmda.go.jp.
⁵ Center for Regulatory Science, Pharmaceuticals and Medical Devices Agency, Kasumigaseki 3-3-2, Chiyoda-ku, Tokyo, 100-0013, Japan. uyama-yoshiaki@pmda.go.jp.
⁶ Graduate School of Medicine, Nagoya University, Nagoya, Japan. uyama-yoshiaki@pmda.go.jp.
⁷ Graduate School of Pharmaceutical Sciences, Nagoya City University, Nagoya, Japan. uyama-yoshiaki@pmda.go.jp.

PMID: 40670856
DOI: 10.1007/s43441-025-00837-4

Abstract

Background: Less participation by Japan in multi-regional clinical trials (MRCTs) is one of concerns that leads to drug loss in Japan, but the characteristics of Japan's participation in MRCTs have not been well studied.

Purpose: This study investigated Japan's situation in global drug development by characterizing its participation in MRCTs compared with East and South-East Asian countries/regions, with a focus on MRCTs sponsored by small-medium companies to discuss necessary measures in further promoting drug development in Japan.

Methods: Data from MRCTs conducted in East and South-East Asia during the period from January 1, 2013 to December 31, 2022 were analyzed.

Results: Japan's participation in MRCTs conducted in Asia (East Asia and South-East Asia) was limited. In particular, Japan participated in only 15-16% of MRCTs sponsored by Small/Medium-pharma (mainly US-based companies), with even less participation in Early Phase MRCTs. Japan's participation in MRCTs was markedly lower than other Asian countries/regions such as Singapore, South Korea, and Taiwan, although it was relatively higher in MRCTs that targeted neoplasms compared with other diseases.

Conclusion: Results of this study raise significant concern about future potential drug loss in Japan. It is urgent to increase the participation of Japan in MRCTs in order to continuously provide new globally developed drugs to patients in Japan. For that purpose, an integrated approach that includes continuous improvement in pharmaceutical regulations and the clinical trial environment, as well as market attractiveness, will be necessary in parallel with strengthening of collaborations between Japan and other Asian countries/regions.

Keywords: Asian collaboration; Drug development; Drug loss; Multi-regional clinical trial; New drug approval.

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Conflict of interest statement

Declarations. Competing Interests: The authors declare no competing interests.

References

1. Ueno T, Asahina Y, Tanaka A, Yamada H, Nakamura M, Uyama Y. Significant differences in drug-lag in clinical development among various strategies used for regulatory submissions in Japan. Clin Pharmacol Ther. 2014;95(5):533–41. - PubMed
1. Maeda H, Kurokawa T. Recent trends for drug lag in clinical development of oncology drugs in Japan: does the oncology drug lag still exist in Japan? Int J Clin Oncol. 2015;20(6):1072–80. - PubMed
1. Noguchi A, Hanaoka H, Uyama Y. Potential future drug development lag in Japan based on an analysis of multiregional clinical trials in the US, europe, and East Asia. Ther Innov Reg Sci. 2022;56(3):523–9.
1. Maki A, Narukawa M. Exploratory analysis of drug lag in new oncology drugs between Japan and the US. Ther Innov Reg Sci. 2023;57(4):671–7.
1. Tanaka M, Idei M, Sakaguchi H, Kato R, Sato D, Sawanobori K, et al. Evolving landscape of new drug approval in Japan and lags from international birth dates: retrospective regulatory analysis. Clin Pharmacol Ther. 2021;109(5):1265–73. - PubMed

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23KC2014/Research grant on regulatory science of pharmaceuticals and medical devices from the Ministry of Health, Labour and Welfare

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[1] Ueno T, Asahina Y, Tanaka A, Yamada H, Nakamura M, Uyama Y. Significant differences in drug-lag in clinical development among various strategies used for regulatory submissions in Japan. Clin Pharmacol Ther. 2014;95(5):533–41. - PubMed

[2] Ueno T, Asahina Y, Tanaka A, Yamada H, Nakamura M, Uyama Y. Significant differences in drug-lag in clinical development among various strategies used for regulatory submissions in Japan. Clin Pharmacol Ther. 2014;95(5):533–41. - PubMed

[3] Maeda H, Kurokawa T. Recent trends for drug lag in clinical development of oncology drugs in Japan: does the oncology drug lag still exist in Japan? Int J Clin Oncol. 2015;20(6):1072–80. - PubMed

[4] Maeda H, Kurokawa T. Recent trends for drug lag in clinical development of oncology drugs in Japan: does the oncology drug lag still exist in Japan? Int J Clin Oncol. 2015;20(6):1072–80. - PubMed

[5] Noguchi A, Hanaoka H, Uyama Y. Potential future drug development lag in Japan based on an analysis of multiregional clinical trials in the US, europe, and East Asia. Ther Innov Reg Sci. 2022;56(3):523–9.

[6] Noguchi A, Hanaoka H, Uyama Y. Potential future drug development lag in Japan based on an analysis of multiregional clinical trials in the US, europe, and East Asia. Ther Innov Reg Sci. 2022;56(3):523–9.

[7] Maki A, Narukawa M. Exploratory analysis of drug lag in new oncology drugs between Japan and the US. Ther Innov Reg Sci. 2023;57(4):671–7.

[8] Maki A, Narukawa M. Exploratory analysis of drug lag in new oncology drugs between Japan and the US. Ther Innov Reg Sci. 2023;57(4):671–7.

[9] Tanaka M, Idei M, Sakaguchi H, Kato R, Sato D, Sawanobori K, et al. Evolving landscape of new drug approval in Japan and lags from international birth dates: retrospective regulatory analysis. Clin Pharmacol Ther. 2021;109(5):1265–73. - PubMed

[10] Tanaka M, Idei M, Sakaguchi H, Kato R, Sato D, Sawanobori K, et al. Evolving landscape of new drug approval in Japan and lags from international birth dates: retrospective regulatory analysis. Clin Pharmacol Ther. 2021;109(5):1265–73. - PubMed

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Characteristics of Multi-Regional Clinical Trials Conducted in Asia, Focusing on Japan's Participation and Small/Medium Companies-Sponsored Trials

Affiliations

Characteristics of Multi-Regional Clinical Trials Conducted in Asia, Focusing on Japan's Participation and Small/Medium Companies-Sponsored Trials

Authors

Affiliations

Abstract

Conflict of interest statement

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Abstract

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