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J R Soc Med. 2015 Mar;108(3):101-7. doi: 10.1177/0141076814557878. Epub 2014 Nov 11.

Under-reporting of conflicts of interest among trialists: a cross-sectional study.

Author information

1
Department of Primary Care and Public Health, Imperial College London, London W6 8RP, UK The Nordic Cochrane Centre, Rigshospitalet Department 7811, 2100 Copenhagen Ø, Denmark kristine.rasmussen12@imperial.ac.uk.
2
The Nordic Cochrane Centre, Rigshospitalet Department 7811, 2100 Copenhagen Ø, Denmark.
3
The Nordic Cochrane Centre, Rigshospitalet Department 7811, 2100 Copenhagen Ø, Denmark Department of Infectious Diseases, Hvidovre University Hospital, 2650 Hvidovre, Denmark.

Abstract

OBJECTIVES:

To determine the prevalence of conflicts of interest (COIs) among Danish physicians who are authors of clinical drug trial reports and determine the extent of undisclosed COIs in trial publications.

DESIGN:

Cross-sectional study.

SETTING:

The 100 most recent drug trial reports with at least one Danish non-industry employed physician author published in a journal adhering to the International Committee of Medical Journal Editors' (ICMJE) manuscript guidelines. For each article, two observers independently extracted trial characteristics and the authors' COIs. Disclosed COIs were compared to what was registered on the Danish Health and Medicines Authority's public disclosure list.

PARTICIPANTS:

Trial authors who are Danish physicians.

MAIN OUTCOME MEASURES:

Number of disclosed and undisclosed COIs.

RESULTS:

One observer screened 928 articles and two observers assessed 120 articles for eligibility. The 100 included trials were published from February 2011 to May 2013 and included 318 Danish non-industry employed authors. Eighty-six of the 318 authors (27%) reported one or more COIs in the journal article. We found undisclosed COIs for 40 of 318 authors (13%) related to the trial sponsor or manufacturer of trial drugs. Seventy-nine of 318 authors (25%) had undisclosed COIs related to competing companies manufacturing drugs for the same indication and 136 (43%) had undisclosed COIs with any drug manufacturer.

CONCLUSIONS:

Almost half of all authors had undisclosed COIs in clinical trials reported in journals adhering to the International Committee of Medical Journal Editors' manuscript guidelines. Self-declared COIs cannot be trusted, but public registries may assist editors in ensuring that more COIs are being reported.

KEYWORDS:

clinical trials; conflicts of interest; disclosure; drug industry

PMID:
25389230
PMCID:
PMC4368454
DOI:
10.1177/0141076814557878
[Indexed for MEDLINE]
Free PMC Article

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