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Characteristics of Industry-Sponsored Drug Clinical Trials Registered in Japan Pharmaceutical Information Center Clinical Trials Information 2010–2018

Therapeutic Innovation & Regulatory Science volume 55, pages 378–387 (2021)Cite this article

Abstract

Purpose

To examine the trends and characteristics of industry-sponsored drug clinical trials registered in the JapicCTI (Japan Pharmaceutical Information Center Clinical Trials Information) in 2010–2018.

Methods

A data set of 3116 clinical trials registered from Jan. 2010 to Dec. 2018 were analyzed. Fundamental characteristics of the clinical trials were analyzed by 3-year time periods. The analysis was also focused on 3 therapeutic areas: cardiovascular, mental health, and oncology.

Results

Of all the trials (2010–2018), 74.7% were conducted in Japan only; the rate decreased from 82.8 to 65.3% over the 3 time periods. Most trials were phase 3 trials, which comprised 44.1% of the trials. Small trials (anticipated number of 1000 or fewer participants) made up 94.0% of the trials. Oncology trials (29.5%) were the most common type and involved more phase 1 trials than mental health and cardiovascular trials (33.6% vs 14.5% and 11.5%, respectively). Oncology trials composed the smallest proportion of trials conducted in “Japan only” at 57.3% vs 81.0% and 83.1% for mental health and cardiovascular trials, respectively (p < 0.001). The median of the anticipated number of participants in mental health trials were larger than those in cardiovascular and oncology trials (p = 0.001). Mental health trials were more likely to permit children under age 15 (10.9% vs 4.9% for cardiovascular and 1.2% for oncology). Oncology trials were more likely not to set an upper age limit (89.8% vs 51.4% for cardiovascular and 41.7% for mental health). Cardiovascular and mental health trials were more likely to be conducted as “double blind” (42.4% and 47.1%, respectively vs 16.7% for oncology).

Conclusion

During this time, the majority of industry-sponsored trials in Japan were phase 3 trials, Japan only and small trials. There were differences in clinical trials among the 3 therapeutic areas: size of the trial, globalization, phase, age of participants, blinding.

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Abbreviations

JPRN:

The Japan Primary Registries Network

JapicCTI:

Japan Pharmaceutical Information Center Clinical Trials Information

JMACCT:

Japan Medical Association Center for Clinical Trials

UMIN-CTR:

The University Hospital Medical Information Network Clinical Trials Registry

jRCT:

Japan Registry of Clinical Trials

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Funding

This study was funded by Health Labour Science Research Grant from the Ministry of Health, Labour and Welfare (19IA2020).

Author information

Affiliations

  1. Department of Social Pharmacy, Graduate School of Pharmaceutical Sciences, Chiba University, 1-8-1 Inohana, Chuo-ku, Chiba-shi, Chiba, 260-8675, Japan

    Eriko Kobayashi

  2. Japan Pharmaceutical Information Center, 2-12-15 Shibuya, Shibuya-ku, Tokyo, 150-0002, Japan

    Midori Matsuyama, Katsue Suzuki & Takahisa Murakami

  3. Department of Clinical Medicine, Graduate School of Pharmaceutical Sciences, Kitasato University, 5-9-1 Shirokane, Minato-ku, Tokyo, 108-8641, Japan

    Mamoru Narukawa

Authors
  1. Eriko Kobayashi
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  2. Midori Matsuyama
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  3. Katsue Suzuki
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  4. Takahisa Murakami
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  5. Mamoru Narukawa
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Contributions

All authors contributed to the discussions and data interpretation contained in this paper and provided input on the manuscript and approved its final version. EK: Conceptualization, data analysis, original draft manuscript preparation. MM: Data curation. KS: Data curation. TM: Manuscript reviewing and editing, coordination. MN; Conceptualization, methodology, manuscript writing, reviewing and editing, and supervision.

Corresponding author

Correspondence to Eriko Kobayashi.

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The authors declare no conflict of interest.

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Kobayashi, E., Matsuyama, M., Suzuki, K. et al. Characteristics of Industry-Sponsored Drug Clinical Trials Registered in Japan Pharmaceutical Information Center Clinical Trials Information 2010–2018. Ther Innov Regul Sci 55, 378–387 (2021). https://doi.org/10.1007/s43441-020-00223-2

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  • DOI: https://doi.org/10.1007/s43441-020-00223-2

Keywords

  • Clinical trial registry
  • Japan Clinical trials
  • Industry-sponsored clinical trials
  • Clinical research design
  • Therapeutic areas studied