Authors of clinical trials seldom reported details when declaring their individual and institutional financial conflicts of interest: a cross-sectional survey

Maram B Hakoum; Hussein Noureldine; Joseph R Habib; Eliane A Abou-Jaoude; Rasha Raslan; Nahla Jouni; Divina Justina Hasbani; Luciane Cruz Lopes; Gordon Guyatt; Elie A Akl

doi:10.1016/j.jclinepi.2020.05.026

Authors of clinical trials seldom reported details when declaring their individual and institutional financial conflicts of interest: a cross-sectional survey

J Clin Epidemiol. 2020 Nov:127:49-58. doi: 10.1016/j.jclinepi.2020.05.026. Epub 2020 Jun 6.

Authors

Affiliations

¹ Department of Family Medicine, Cornerstone Care Teaching Health Center, Waynesburg, PA, USA.
² Gilbert and Rose-Marie Chagoury School of Medicine, Lebanese American University, Byblos, Lebanon.
³ Faculty of Medicine, American University of Beirut, Beirut, Lebanon.
⁴ Department of Internal Medicine, State University of New York at Buffalo, Buffalo, NY, USA.
⁵ Department of Internal Medicine, Virginia Commonwealth University, Richmond, VA, USA.
⁶ Faculty of Agriculture and Food Sciences, American University of Beirut, Beirut, Lebanon.
⁷ Graduate Program of Pharmaceutical Sciences, University of Sorocaba, São Paulo, Brazil.
⁸ Department of Health Research Methods, Evidence, and Impact, McMaster University, Hamilton, Ontario, Canada.
⁹ Department of Health Research Methods, Evidence, and Impact, McMaster University, Hamilton, Ontario, Canada; Department of Internal Medicine, American University of Beirut Medical Center, Beirut, Lebanon. Electronic address: ea32@aub.edu.lb.

PMID: 32512186
DOI: 10.1016/j.jclinepi.2020.05.026

Abstract

Background: The main objective of this study was to document details of both individual and institutional financial conflicts of interest (FCOIs) reported by the authors of clinical trials. An additional objective was to assess the predictors of having at least one author reporting any FCOI.

Methods: We used a sample of randomized controlled trials from a previous cross-sectional survey and included the trials, which reported at least one FCOI disclosure. We categorized the types of disclosed FCOI as grant, employment income, personal fees, nonmonetary support, drug or equipment supplies, patent, stocks, and other types. We collected data on the characteristics of the included RCTs, of the authors, and of the reported FCOI disclosures. We conducted descriptive analyses and a regression analysis to assess the predictors of having at least one author reporting any FCOI.

Results: All 108 included RCTs reported being funded, with 58% reporting funding by a private-for-profit source. Out of 1,687 authors, 814 (48%) reported at least one, and a median of 2, FCOI disclosures. Of the 814 reporting disclosures, far more reported individual FCOIs (99%) than institutional FCOIs (6%). The most commonly reported individual FCOI subtypes were grant (49%), personal fees (48%), and employment income (22%). Of the 99% of disclosures that included the source of FCOI, a private-for-profit entity provided the funds in 85%. Reporting about the relation of the FCOI source's to the product investigated in the trial, the timing of FCOI, and monetary value of FCOI was limited. Reporting of FCOIs proved most strongly associated with author affiliation being an academic institution (OR = 2.981; 95% CI: 2.415-3.680) and trial funding from entity other than a private-for-profit entity (OR = 2.809; 95% CI: 2.274-3.470).

Conclusion: Approximately half of the trial authors report individual FCOIs, often three or more, but seldom provide details related to source's relation to the trial, or the timing and monetary value of the FCOI.

Keywords: COI declaration; COI reporting; Financial conflicts of interest; Individual COI; Institutional COI; Randomized controlled trial.

Publication types

Research Support, Non-U.S. Gov't

MeSH terms

Authorship*
Conflict of Interest / economics*
Cross-Sectional Studies
Disclosure / statistics & numerical data*
Ethics, Institutional*
Fees and Charges / statistics & numerical data
Financing, Organized / statistics & numerical data
Humans
Income / statistics & numerical data
Organizational Affiliation
Randomized Controlled Trials as Topic / ethics*
Randomized Controlled Trials as Topic / statistics & numerical data
Regression Analysis
Research Support as Topic / economics
Research Support as Topic / statistics & numerical data