Research on policy mechanisms to address funding bias and conflicts of interest in biomedical research: a scoping review

Abstract

Background: Industry funding and author conflicts of interest (COI) have been consistently shown to introduce bias into agenda-setting and results-reporting in biomedical research. Accordingly, maintaining public trust, diminishing patient harm, and securing the integrity of the biomedical research enterprise are critical policy priorities. In this context, a coordinated and methodical research effort is required to effectively identify which policy interventions are most likely to mitigate against the risks of funding bias. Subsequently this scoping review aims to identify and synthesize the available research on policy mechanisms designed to address funding bias and COI in biomedical research.

Methods: We searched PubMed for peer-reviewed, empirical analyses of policy mechanisms designed to address industry sponsorship of research studies, author industry affiliation, and author COI at any stage of the biomedical research process and published between January 2009 and 28 August 2023. The review identified literature conducting five primary analysis types: (1) surveys of COI policies, (2) disclosure compliance analyses, (3) disclosure concordance analyses, (4) COI policy effects analyses, and (5) studies of policy perceptions and contexts. Most available research is devoted to evaluating the prevalence, nature, and effects of author COI disclosure policies.

Results: Six thousand three hundreds eighty five articles were screened, and 81 studies were included. Studies were conducted in 11 geographic regions, with studies of international scope being the most common. Most available research is devoted to evaluating the prevalence, nature, and effects of author COI disclosure policies. This evidence demonstrates that while disclosure policies are pervasive, those policies are not consistently designed, implemented, or enforced. The available evidence also indicates that COI disclosure policies are not particularly effective in mitigating risk of bias or subsequent negative externalities.

Conclusions: The results of this review indicate that the COI policy landscape could benefit from a significant shift in the research agenda. The available literature predominantly focuses on a single policy intervention-author disclosure requirements. As a result, new lines of research are needed to establish a more robust evidence-based policy landscape. There is a particular need for implementation research, greater attention to the structural conditions that create COI, and evaluation of policy mechanisms other than disclosure.

Keywords: Competing interests; Conflicts of interest; Funding bias; Meta-research; Research integrity policy.

Fig. 1

PRISMA-SCR flowchart for identification of included studies

Fig. 2

Reported Prevalence (%) of Biomedical Journals with COI Policies for Groups Covered (Authors, Editors, or Referees) by Year. Each point is an induvial study, and point size represents study N (journals). Temporal trends visualized with loess [25]

Fig. 3

Reported Compliance with COI and/or funding disclosure requirements by population type (Conference Presentations, Journal Articles, or Meta-Analyses. Each point is an induvial study, and point size represents study N (research outputs). N = 27, excludes Kesselheim, Temporal trends visualized with linear regression. Loess was disallowed due to data sparsity

Fig. 4

Reported Disclosure Concordance by Comparator Data Set (Legal and Regulatory Filings, Public Payment Databases, and Subsequent Research Outputs). Each point is an individual study; point-size represents study N (research outputs), and study population (journal articles, conference presentations, or both) are indicated by point color