Science and Engineering Ethics

, Volume 24, Issue 6, pp 1809–1811 | Cite as

Conflict of Interest and the CREATE-X Trial in the New England Journal of Medicine

  • Akihiko OzakiEmail author


There is an increasing emphasis on clear disclosure of conflict of interest in medical communities, following repeated scientific frauds in clinical trials. However, incomplete COI statements continue to be prevalent in the medical community, as appears to have occurred in the Capecitabine for Residual Cancer as Adjuvant Therapy (CREATE-X) trial, which was recently published in the New England Journal of Medicine. The authors of the article did not clearly report the roles of the Japan Breast Cancer Research Group, a sponsor and funder of the study, although a majority of the Japanese authors served in important positions in the organization. Furthermore, the conflict of interest related to Chugai Pharmaceutical Company, a Japanese distributor of capecitabine, was not correctly disclosed. More transparent statements of conflict of interest and clarification of sponsors and funders’ roles, as well as rigorous review by academic journals are required to fairly interpret the findings of clinical trials, including and beyond the single case of the CREATE-X trial.


Conflict of interest Capecitabine Breast cancer Clinical trial New England Journal of Medicine 


Compliance with Ethical Standards

Conflict of interest

The author declares that there is no conflict of interest.


  1. Chugai Pharmaceutical Company. (2017). Funding to medical institutions and individuals (in Japanese). Available at: Accessed 22 August 2017.
  2. Japan Breast Cancer Research Group. (2017). Home page of Japan Breast Cancer Research Group. Available at: Accessed 22 August 2017.
  3. Masuda, N., Lee, S. J., Ohtani, S., Im, Y. H., Lee, E. S., Kuroi, K., et al. (2017). Adjuvant capecitabine for breast cancer after preoperative chemotherapy. New England Journal of Medicine, 376(22), 2147–2159.CrossRefGoogle Scholar
  4. National Comprehensive Cancer Network. (2017). NCCN clinical practice guidelines on oncology (NCCN guidelines) breast cancer version 2.2017—April 6, 2017. Available at: Accessed 22 August 2017.
  5. Toi, M., Masuda, N., & Ohashi, Y. (2017). Adjuvant capecitabine for breast cancer. New England Journal of Medicine, 377(8), 791–792.Google Scholar

Copyright information

© Springer Science+Business Media B.V. 2017

Authors and Affiliations

  1. 1.Department of SurgeryMinamisoma Municipal General HospitalMinamisomaJapan
  2. 2.Teikyo University Graduate School of Public HealthItabashi-kuJapan

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