poster
Accuracy of Conflict of Interest Disclosure Among Australian Clinical Trial Authors
keywords:
conflict of interest
reporting guidelines
bias
Objective Authors’ financial ties with pharmaceutical
companies can affect the design, conduct, and reporting of
clinical trials of drug treatments.1 Although disclosure does
not eliminate conflicts of interest (COI), it allows readers and
reviewers to consider potential effects. There has been little
research on the accuracy of authors’ COI disclosures outside
the US.2,3 However, since 2015, Medicines Australia (MA),
Australia’s research-based pharmaceutical industry
association, has required member companies to report
payments provided to individual clinicians. This study
assessed how often Australian clinical trial authors accurately
report pharmaceutical industry financing by comparing
authors’ self-reported COI in published articles with MA
payments data, using the International Committee of Medical
Journal Editors (ICMJE) criteria to assess adequacy of
disclosure. A secondary analysis compared numbers of
authors per trial with inaccurate disclosures in journals with
author instructions consistent with ICMJE standards, as
compared with journals with weaker disclosure instructions.
Design This was a cross-sectional study. To identify
Australian authors of recent randomized clinical trials
(RCTs), Ovid Medline was searched from January to August
2020 using a Cochrane RCT search filter, limited by mention
of Australia anywhere in the text, including author
affiliations. RCTs that tested prescription-only medicines and
vaccines in clinical populations were included. Two
researchers independently compared authors’ disclosures in
included trials with information in the MA database,
assessing payments from companies operating in the relevant
commercial space within a 3-year period before article
submission. Relevant commercial space was defined as
marketing products for the same condition or therapeutic
class, as per ICMJE criteria. Journals’ instructions for authors
on COI disclosure were classified according to consistency
with ICMJE criteria. To compare Australian and US authors’
reporting rates, the subset of trials with US authors was
identified, and US Open Payments data on general payments
(excluding food and beverage) were used to match MA data.
Results Of 583 unique identified records, 120 met inclusion
criteria as drug trials with 1 or more Australian authors. In
total, 56 of 120 trials (47 %) had 1 or more authors with
undisclosed COI, and 78 of 323 Australian authors (24%) had
undisclosed COI (89 nondisclosures). Among the remaining
authors, 129 of 323 (40%) had accurate declarations. We
could not assess disclosure accuracy for 116 of 323
nonclinicians (36%). The most common type of nondisclosure
was incorrectly declaring no COI (46 52%), followed by
partial disclosures (39 44%). The median value of
undisclosed payments was $8,944 (range, $140-$97,600)
Australian dollars. Author nondisclosure rate per trial was
similar whether or not journals applied ICMJE criteria: 40%
vs 45% (P = .51).
Conclusions In this sample of recent RCTs with Australian
authors, inaccurate and incomplete COI declarations were
common. These discrepancies highlight the need for more
transparent and comprehensive COI reporting.
References
1. Fabbri A, Lai A, Grundy Q, Bero LA. The influence of
industry sponsorship on the research agenda: a scoping
review. Am J Public Health. 2018;108:e9-e16. Medline:
30252531 doi:10.2105/AJPH.2018.304677
2. Taheri C, Kirubarajan A, Li X, et al. Discrepancies in
self-reported financial conflicts of interest disclosures by
physicians: a systematic review. BMJ Open. 2021;11:e045306.
doi:10.1136/bmjopen-2020-045306
3. Rasmussen K, Schroll J, Gøtzsche PC, Lundh A.
Underreporting of conflicts of interest among trialists: a
cross-sectional study. J R Soc Med. 2015;108(3):101-107.
doi:10.1177/0141076814557878
Conflict of Interest Disclosures None reported.
Funding/Support This work was funded by grant AKF2020192
from the Australia Korea Foundation, Department of Foreign
Affairs and Trade, and by a University of Sydney and Yonsei
University Partnership Collaboration Award.
Role of the Funders/Sponsor Neither funder had any role in the
design and conduct of the study; collection, management, analysis,
and interpretation of the data; preparation, review, or approval of
the abstract; and decision to submit the abstract for presentation.
Additional Information Bennett Holman is a co–corresponding
author.