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Surveillance of protocol deviations in Japanese oncology registration trials: a single institute experience

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Summary

Background The contents and requirements of study protocols vary depending upon each clinical registration trial. This study aims to describe details of protocol deviations in Japanese oncology registration trials. Methods We reviewed deviation reports that were discussed by the Institutional Review Board between 2010 and 2015. Results A total of 499 clinical trials were performed, from which 967 deviations were reported. In the initial 3 years, 445 deviations occurred in 535 ongoing trials, while 522 deviations occurred in 876 trials in the subsequent 3 years. The frequency of deviations related to visit, examination, treatment, and others was 189 (19.5%), 446 (46.1%), 275 (28.4%), and 57 (5.9%), respectively. Serious deviations were common at the time of registration of trials and during treatment. The deviations were attributable to the institution (n = 520), subject (n = 93), sponsor (n = 28), schedule management (n = 162), disease condition (n = 95), and others (n = 69). Conclusion This study showed the number and detail responsible factors of protocol deviations. Our findings support to distinguish between the measures to reduce the serious deviations and to reduce the overall number of deviations.

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Acknowledgements

We would like to thank Editage (www.editage.jp) for English language editing.

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Authors and Affiliations

  1. Department of Breast and Medical Oncology, National Cancer Center Hospital, Tokyo, Japan

    Shinsuke Sasada & Kenji Tamura

  2. Clinical Trial Coordination and Support Office, National Cancer Center Hospital, Tokyo, Japan

    Nobuko Ushirozawa, Noriko Kobayashi & Noboru Yamamoto

  3. Department of Experimental Therapeutics, National Cancer Center Hospital, Tsukiji 5-1-1, Chuo-Ku, Tokyo, 104-0045, Japan

    Yutaka Fujiwara, Kenji Tamura & Noboru Yamamoto

Authors
  1. Shinsuke Sasada
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  2. Nobuko Ushirozawa
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  3. Noriko Kobayashi
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  4. Yutaka Fujiwara
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  5. Kenji Tamura
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  6. Noboru Yamamoto
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Correspondence to Noboru Yamamoto.

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This work was not supported by any funding sources.

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This article does not contain any studies with human participants or animals performed by any of the authors.

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Sasada, S., Ushirozawa, N., Kobayashi, N. et al. Surveillance of protocol deviations in Japanese oncology registration trials: a single institute experience. Invest New Drugs 35, 392–396 (2017). https://doi.org/10.1007/s10637-017-0434-3

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  • DOI: https://doi.org/10.1007/s10637-017-0434-3

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