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Experimental therapies

Investigator-initiated cancer trials with INDs for approval in Japan

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From Nature Reviews Clinical Oncology

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In Japan, it is quite rare for an investigator to submit an investigational new drug application to initiate a clinical trial and obtain approval of a drug on the basis of clinical trial results. This means that development of new therapies is currently driven almost entirely by pharmaceutical companies as opposed to independent investigators. Here, we provide our perspective on the reasons for this situation and advocate investigator-initiated cancer drug development as a means of increasing access to better therapies for Japanese cancer patients.

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Authors and Affiliations

  1. Department of Clinical Pharmacokinetics and Pharmacodynamics, School of Medicine, Keio University, 35 Shinano-machi, Shinjuku-ku, 160-8582, Tokyo, Japan

    Chiyo K. Imamura

  2. Cancer Therapy Evaluation Program, National Cancer Institute, National Institutes of Health, 6130 Executive Boulevard, Rockville, 20852, MD, USA

    Naoko Takebe

  3. Department of Breast Surgical Oncology, St. Luke's International Hospital, 9-1 Akashi-cho, Chuo-ku, 104-8560, Tokyo, Japan

    Seigo Nakamura

  4. Division of Gene Regulation, Institute for Advanced Medical Research, School of Medicine, Keio University, 35 Shinano-machi, Shinjuku-ku, 160-8582, Tokyo, Japan

    Hideyuki Saya

  5. Department of Breast Medical Oncology, The University of Texas M. D. Anderson Cancer Center, 1515 Holcombe Boulevard, Unit 1354, Houston, 77030, TX, USA

    Naoto T. Ueno

Authors
  1. Chiyo K. Imamura
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  2. Naoko Takebe
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  3. Seigo Nakamura
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  4. Hideyuki Saya
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  5. Naoto T. Ueno
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Corresponding author

Correspondence to Naoto T. Ueno.

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The authors declare no competing financial interests.

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Imamura, C., Takebe, N., Nakamura, S. et al. Investigator-initiated cancer trials with INDs for approval in Japan. Nat Rev Clin Oncol 7, 127–128 (2010). https://doi.org/10.1038/nrclinonc.2010.13

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  • DOI: https://doi.org/10.1038/nrclinonc.2010.13

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