Accuracy of post-publication Financial Conflict of Interest corrections in medical research: A secondary analysis of pharmaceutical company payments to the authors of the CREATE-X trial report in the New England Journal of Medicine

Bioethics. 2021 Sep;35(7):704-713. doi: 10.1111/bioe.12854. Epub 2021 Jun 16.

Abstract

In June 2017, Japanese and Korean authors published the results of the CREATE-X trial in the New England Journal of Medicine (NEJM). After we identified their inadequate disclosures of Financial Conflict of Interests (FCOIs), the authors made a post-publication correction of their FCOIs. The purpose of this study is to evaluate the accuracy of the post-publication corrections by the Japanese authors of the CREATE-X trial. All the Japanese authors of the CREATE-X trial were included in the study. We determined the payments received by these authors in 2016 using publicly available data published by 78 pharmaceutical companies based on the stipulated Japanese transparency guidelines. We retrieved the original and revised versions of the FCOI disclosures as published on the NEJM website, and compared the payments reported by the pharmaceutical companies and the original and revised FCOI disclosures of the authors. Of the 12 authors, nine received payments made by the drug manufacturer involved in the CREATE-X trial. Of these nine, only three (33.3%) originally disclosed their relationships, and another three (33.3%) later disclosed such relationships in the post-publication corrections. Similarly, of the 11 receiving at least one payment from other manufacturers of breast cancer products, none correctly disclosed the payments in the original or the revised disclosure. In the CREATE-X trial, FCOIs with pharmaceutical companies were not properly disclosed by 11 of the 12 Japanese authors, even after the post-publication corrections, which highlights the need to pay more attention to the accuracy of FCOI disclosures in academic publications.

Keywords: CREATE-X trial; Japan; breast cancer; conflict of interest; pharmaceutical company.

Publication types

  • Research Support, Non-U.S. Gov't

MeSH terms

  • Biomedical Research*
  • Conflict of Interest
  • Disclosure
  • Humans
  • Pharmaceutical Preparations*

Substances

  • Pharmaceutical Preparations