Lorelie Flood,1 Barbara Mintzes,1 Kellia Chiu,1 Zhaoli Dai,1,2 Emily A. Karanges,3,4 Bennett Holman5,6
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.
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.
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).
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.
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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
1Charles Perkins Centre, School of Pharmacy, Faculty of Medicine and Health, The University of Sydney, Camperdown, New South Wales, Australia, Barbara.email@example.com; 2College of Medicine and Public Health, Flinders University, Bedford Park, South Australia, Australia; 3Centre for Youth Mental Health, The University of Melbourne, Melbourne, Australia; 4Orygen, Melbourne, Victoria, Australia; 5Underwood International College, Yonsei University, Incheon, Korea; 6Faculty of Humanities, University of Johannesburg, Johannesburg, South Africa
Conflict of Interest Disclosures
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.
Bennett Holman is a co–corresponding author.