Literature DB >> 28916944

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

Akihiko Ozaki1,2.   

Abstract

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.

Entities:  

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

Mesh:

Substances:

Year:  2017        PMID: 28916944     DOI: 10.1007/s11948-017-9966-3

Source DB:  PubMed          Journal:  Sci Eng Ethics        ISSN: 1353-3452            Impact factor:   3.525


  2 in total

1.  Adjuvant Capecitabine for Breast Cancer.

Authors:  Masakazu Toi; Norikazu Masuda; Yasuo Ohashi
Journal:  N Engl J Med       Date:  2017-08-24       Impact factor: 91.245

2.  Adjuvant Capecitabine for Breast Cancer after Preoperative Chemotherapy.

Authors:  Norikazu Masuda; Soo-Jung Lee; Shoichiro Ohtani; Young-Hyuck Im; Eun-Sook Lee; Isao Yokota; Katsumasa Kuroi; Seock-Ah Im; Byeong-Woo Park; Sung-Bae Kim; Yasuhiro Yanagita; Shinji Ohno; Shintaro Takao; Kenjiro Aogi; Hiroji Iwata; Joon Jeong; Aeree Kim; Kyong-Hwa Park; Hironobu Sasano; Yasuo Ohashi; Masakazu Toi
Journal:  N Engl J Med       Date:  2017-06-01       Impact factor: 91.245

  2 in total
  4 in total

1.  A call for improved transparency in financial aspects of clinical trials: a case study of the CREATE-X trial in the New England Journal of Medicine.

Authors:  Akihiko Ozaki; Morihito Takita; Tetsuya Tanimoto
Journal:  Invest New Drugs       Date:  2018-03-08       Impact factor: 3.850

2.  A cross-sectional examination of conflict-of-interest disclosures of physician-authors publishing in high-impact US medical journals.

Authors:  James H Baraldi; Steven A Picozzo; Jacob C Arnold; Kathryn Volarich; Michael R Gionfriddo; Brian J Piper
Journal:  BMJ Open       Date:  2022-04-11       Impact factor: 3.006

3.  Pharmaceutical payments to certified oncology specialists in Japan in 2016: a retrospective observational cross-sectional analysis.

Authors:  Akihiko Ozaki; Hiroaki Saito; Yosuke Onoue; Toyoaki Sawano; Yuki Shimada; Yurie Somekawa; Aritsune Tsuji; Tetsuya Tanimoto
Journal:  BMJ Open       Date:  2019-09-06       Impact factor: 2.692

4.  How Do Institutional Conflicts of Interest Between Pharmaceutical Companies and the Healthcare Sector Become Corrupt? A Case Study of Scholarship Donations Between Department of Clinical Anesthesiology, Mie University, and Ono Pharmaceutical in Japan.

Authors:  Akihiko Ozaki; Anju Murayama; Kayo Harada; Hiroaki Saito; Toyoaki Sawano; Tetsuya Tanimoto; Piotr Ozieranski
Journal:  Front Public Health       Date:  2022-01-03
  4 in total

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