Reporting of drug trial funding sources and author financial conflicts of interest in Cochrane and non-Cochrane meta-analyses: a cross-sectional study

Carboni-Jiménez, Andrea; Benea, Carla; Elder, Katharine; Levis, Brooke; Boruff, Jill; Roseman, Michelle; Bero, Lisa; Lexchin, Joel; Turner, Erick H.; Benedetti, Andrea; Thombs, Brett D.

doi:10.1136/bmjopen-2019-035633

Cited by 9 publications

(6 citation statements)

References 19 publications

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“…In our sample, only 8/44 (18%) SR reported information on con ict of interest of the included primary studies. This is similar to an investigation of non-Cochrane reviews in which 15% of SR had reports on funding for the included primary studies [24]. Con ict of interest among authors of primary studies may also be associated with tactical choices on control groups or comparative interventions [25].…”

Section: Discussionsupporting

confidence: 60%

Conflict of Interest and Risk of Bias in Systematic Reviews on Methylphenidate for Attention Deficit Hyperactivity Disorder

Snellman

Carlberg

Olsson

2023

Preprint

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Background Systematic reviews (SR) are crucial to evidence-based medicine, but associated conflict of interest remains under-investigated. We set out to compare disclosure of financial conflicts of interest (fCOI) of authors with publically available information and risk of bias (RoB) in SR on the effect of Methylphenidate for treatment of Attention Deficit Hyperactivity Disorder. Methods A librarian searched Medline, Cochrane Library, Embase and PsycInfo in December, 2020. PRISMA guidelines were adopted for selection. Two blinded researchers independently searched open websites for information on fCOI for all authors of all included SR. ´ Disclosure on fCOI was extracted from full-text versions of SR. RoB was judged using Cochrane´s tool for SR. Results Disclosure on fCOI was missing for 2/44 (5%) included SR. For 15 (34%) SR, at least one author disclosed fCOI, and confirmed by open websites in all cases. Authors of 27 (61%) SR disclosed no fCOI, but discordant information was publically available for 8 (30%). In all, 23/44 (55%) of SR were associated with fCOI. RoB was high for 37/44 (84%) SR; 18 (49%) with and 19 (51%) without fCOI noticed on open websites. For the remaining 7 SR with low risk of bias, the corresponding figures were 6 (86%) with and 1 (14%) without fCOI. Conclusion The findings indicated an underreporting of fCOI corresponding to one third of SR disclosing no fCOI, methodological shortcomings were common, and 43/44 (98%) SR were compromised by either high RoB, or by fCOI. Similar investigations on other topics for comparison are warranted.

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Section: Discussionsupporting

confidence: 60%

Conflict of Interest and Risk of Bias in Systematic Reviews on Methylphenidate for Attention Deficit Hyperactivity Disorder

Snellman

Carlberg

Olsson

2023

Preprint

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“…However, the results of this study showed that in only 54.17% of MAs the FCOIs of the included primary studies were reported and listed in detail, whereas in only 21.88% of MAs, author-industry-related financial ties of included trials were reported. In a recent study, it was demonstrated that the reporting of non-Cochrane SRs and MAs on the financial relationship of the author-industry was only 1%, 39 which is far from acceptable.…”

Section: Discussionmentioning

confidence: 98%

The Impact of Drug Trials With Financial Conflict of Interests on the Meta-analyses: A Meta-epidemiological Study

Zhang

Yan

Zhao

et al. 2021

Int J Health Policy Manag

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Background: Drug trials with potential financial conflict of interests (FCOIs) may influence trial design, drug dosage, comparators, and promising results are more likely to be reported. The objective of this study was to assess the impact of trials with FCOIs on evidence synthesis in meta-analyses (MAs). Methods: A total of 96 MAs from the Cochrane Library about drug trials were investigated. The primary outcomes examined the proportion of conclusions that would change with the exclusion of trials with potential FCOIs. If the proportion of changed conclusions was below the non-inferiority margin of 10%, we considered that it was not inferior to include the trials with potential FCOIs in the MAs. Results: Only 54.17% of MAs reported the funding sources of each included trial, and in 21.88% of MAs, the author-industry-related financial ties of each included trial were reported. When trials with FCOIs were excluded, the changed conclusions of effectiveness and major adverse events were 13.16% and 11.11%, respectively, and the I 2 decreased by 13.56% and 10.09%, respectively. For serious adverse events, the exclusion of FCOIs trials did not lead to any change in conclusions; however, the I 2 decreased by 24.24%. The impact of trials without reported FCOIs was also examined on evidence synthesis, and the results showed that the changed conclusions of effectiveness and major adverse events were 5.26% and 6.25%, respectively, indicating non-inferiority. However, the I 2 increased by 13.60% and 12.37%, respectively. Conclusion: In this meta-epidemiological study, we demonstrated that trials with FCOIs may not only influence the final outcome of MAs but may also increase the heterogeneity of results. It is suggested that all MAs fully report the FCOIs involved in evidence-based research and explore the impact of its FCOIs to better provide a more valuable reference for patients, clinicians, and policymakers.

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“…A troublesome finding of this study, in our opinion, was the low frequency of SRs that presented data on financial conflict of interest among the included primary (8/44; 18%). However, according to a recent study on 250 meta-analyses, author-industry financial ties of the included trials were reported in only 1% of non-Cochrane and 44% of Cochrane meta-analyses [ 20 ]. Conflict of interest among the authors of primary studies may be associated with, e.g., tactical choices on control groups or comparative interventions [ 21 ], and we understand that information on competing interests related to the included primary studies is essential to all the end-users of SRs.…”

Section: Discussionmentioning

confidence: 99%

Conflict of interest and risk of bias in systematic reviews on methylphenidate for attention-deficit hyperactivity disorder: a cross-sectional study

Snellman,

Carlberg,

Olsson

2023

Syst Rev

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Background Systematic reviews (SRs) are pivotal to evidence-based medicine, yet there is limited research on conflicts of interest in SRs. Our aim was to investigate financial conflicts of interest and risk of bias (RoB) in SRs of a well-defined clinical topic. Methods A librarian searched Medline, Cochrane Library, Embase, and PsycINFO for SRs investigating the effect of methylphenidate on ADHD in December 2020. The selection process adhered to the PRISMA guidelines. Two blinded reviewers independently searched open websites, including other publications, for information on financial conflicts of interest of all authors of the included SRs. A time limit of 3 years before or after the index SR was adopted. Declarations on conflict of interest were extracted from the included SRs for comparison. ROBIS was used for RoB assessment. Results Out of 44 SRs included, 15 (34%) declared conflict of interest, 27 (61%) did not, and a declaration of conflict of interest was missing for 2 (5%). On open websites, conflict of interest was found for at least one author of 23 (52%) SRs: disclosed in 15 (34%) and not disclosed in 8 (18%) SRs. Seven (16%) SRs had low, 36 (82%) had high, and 1 (2%) had unclear RoB. Among SRs with financial conflict of interest found in open sources, 6/22 (27%) had low RoB compared to 1/21 (5%) if no such conflict of interest was identified. Among SRs with financial conflict of interest identified, 1/6 (17%) at low RoB did not disclose their conflict of interest, whereas the corresponding proportion among SRs at high RoB was 7/16 (44%). Eight (18%) SRs presented conflict of interest disclosed in the included primary studies. Four of them (50%) had low RoB, compared to 3/36 (8%) for SRs not reporting on this aspect. Conclusion Financial conflict of interest was underreported in 18% of the SRs using our reference standard, and overall it was present for every second SR. This group embraced both SRs at low RoB disclosing conflict of interest and SRs at high RoB not disclosing their conflict of interest. Further studies to explore this heterogeneity are warranted.

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Reporting of drug trial funding sources and author financial conflicts of interest in Cochrane and non-Cochrane meta-analyses: a cross-sectional study

Cited by 9 publications

References 19 publications

Conflict of Interest and Risk of Bias in Systematic Reviews on Methylphenidate for Attention Deficit Hyperactivity Disorder

Conflict of Interest and Risk of Bias in Systematic Reviews on Methylphenidate for Attention Deficit Hyperactivity Disorder

The Impact of Drug Trials With Financial Conflict of Interests on the Meta-analyses: A Meta-epidemiological Study

Conflict of interest and risk of bias in systematic reviews on methylphenidate for attention-deficit hyperactivity disorder: a cross-sectional study

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