scholarly journals Financial Conflicts of Interest Change After a High-Impact Clinical Trial Publication in Oncology

2020 ◽  
Vol 7 (3) ◽  
pp. 249-254
Author(s):  
Craig L. Cambridge ◽  
Emily Stern Gatof ◽  
Glen J. Weiss ◽  
Roger B. Davis
Neurology ◽  
2021 ◽  
pp. 10.1212/WNL.0000000000011701
Author(s):  
Jade Smith ◽  
Charlotte Wahle ◽  
James L. Bernat ◽  
Nathaniel M. Robbins

ObjectiveTo detail the scope, nature, and disclosure of financial conflicts of interest (COI) between the pharmaceutical and medical device industries (Industry) and authors in high-impact clinical neurology journals.MethodsUsing the Centers for Medicare and Medicaid Services Open Payments database (OPD), we retrieved information on payments from Industry to 2,000 authors from randomly selected 2016 articles in 5 journals. We categorized payments by type (Research, General, and Associated Research/institutional), sponsoring entity, and year (from 2013 to 2016). Each author's self-disclosures were compared to OPD-listed Industry relationships to measure discordance. Payments were manually reviewed to identify those from manufacturers of products that were directly tested or discussed in the article. We also quantified the prevalence and value of these nondisclosed, relevant COI.ResultsTwo hundred authors from 158 articles had at least one OPD payment. Median/mean annual payments per author were $4,229/$19,586 (General); $1,702/$5,966 (Research); and $67,512/$362,102 (Associated Research). Most neurologists received <$1,000/y (74.6%, 93.0%, and 79.5% for General, Research, and Associated Research, respectively), but a sizeable minority (>10% of authors) received more than $10,000 per year, and several received over $1 million. Of 3,013 payments deemed directly relevant to the article, 39.7% were not self-disclosed by the authors, totaling $3,379,093 ($1,446,603 General; $25,532 Research; $1,906,958 Associated Research).ConclusionIndustry-related financial relationships are prevalent among US-based physicians publishing in major neurology journals, and incomplete self-disclosure is common. As a profession, academic and other neurologists must work to establish firm rules to ensure and manage disclosure of financial COI.


2020 ◽  
Author(s):  
Kimberly A. Turner ◽  
Andrea Carboni Jimenez ◽  
Carla Benea ◽  
Katharine Elder ◽  
Brooke Levis ◽  
...  

Background: A previous study found that 2 of 29 (6.9%) meta-analyses published in high-impact journals in 2009 reported included drug trials’ funding sources, and none reported trial authors’ financial conflicts of interest (FCOIs) or industry employment. It is not known if reporting has improved since 2009. Our objectives were to (1) investigate the extent to which pharmaceutical industry funding and author-industry FCOIs and employment from included drug trials are reported in meta-analyses published in high-impact journals; and (2) compare current reporting with results from 2009.Methods: We searched PubMed (January 2017 – October 2018) for systematic reviews with meta-analyses including ≥ 2 randomized controlled trials (RCTs) of patented drugs. We included 3 meta-analyses published January 2017-October 2018 from each of 4 high-impact general medicine journals, high-impact journals from 5 specialty areas, and the Cochrane Database of Systematic Reviews, as in the previous study. Results: Among 29 meta-analyses reviewed, 13 of 29 (44.8%) reported the funding source of included trials compared to 2 of 29 (6.9%) in 2009, a difference of 37.9% (95% confidence interval, 15.7% to 56.3%); this included 7 of 11 (63.6%) from general medicine journals, 3 of 15 (20.0%) from specialty medicine journals, and 3 of 3 (100%) Cochrane reviews. Only 2 of 29 meta-analyses (6.9%) reported trial author FCOIs, and none reported trial author-industry employment.Protocol Publication: (https://osf.io/8xt5p/) Limitations: We examined only a relatively small number of meta-analyses from selected high-impact journals and compared results to a similarly small sample from an earlier time period.Conclusions: Reporting of drug trial sponsorship and author FCOIs in meta-analyses published in high-impact journals has increased since 2009 but is still suboptimal. Standards on reporting of trial funding described in the forthcoming revised PRISMA statement should be adapted and enforced by journals to improve reporting.


2021 ◽  
Vol 4 (Supplement_1) ◽  
pp. 168-170
Author(s):  
K Elsolh ◽  
D Tham ◽  
M A Scaffidi ◽  
R Bansal ◽  
J Li ◽  
...  

Abstract Background Inflammatory Bowel Disease (IBD) studies have commonly relied on real-world evidence to evaluate different therapies. An emerging idea has been the use of propensity score matching as a statistical method to account for baseline characteristics in IBD patients. In retrospective studies, propensity score matching of patients helps reduce treatment assignment bias and mimic the effects of randomization. Recently, propensity-score matching has become an important tool in IBD studies comparing biologic therapeutics. Biologic medications are among the highest-grossing drugs worldwide, and their pharmaceutical producers make considerable payments to physicians to market them. In spite of this, there is a lack of evidence examining the role of undue industry influence among propensity-score matched comparative studies evaluating biologic therapeutics for IBD. Aims Given the documented association between IBD biologics and FCOI, we hypothesize a high burden of FCOI in propensity-score matched studies. The aim of this study was to evaluate the prevalence of disclosed & undisclosed financial conflicts of Interest (FCOI) in propensity-score matched comparison studies evaluating biologics for IBD. Methods We developed & ran a librarian-reviewed systematic search on EMBASE, MEDLINE, and Cochrane Library databases for all propensity-score matched retrospective studies comparing biologics for the treatment of IBD. Full-text retrieval & screening was performed on all studies in duplicate. 16 articles were identified. Industry payments to authors were only considered FCOI if they were made by a company producing a biologic that was included in the comparison study. Disclosed FCOI were identified by authors’ interests disclosures in full-texts. Any undisclosed FCOI among US authors were identified using the Centre for Medicare and Medicaid Services (CMS) Open Payments Database, which collects industry payments to physicians. Results Based on a preliminary analysis of 16 studies, there was at least one author with a relevant FCOI in 14 (88%) of the 16 studies. 14 studies (88%) had at least one disclosed FCOI, while 6 studies (37.5%) had at least one undisclosed FCOI. Among studies with disclosed FCOI, a mean of 40.2% (SD = 23.4%) of authors/study reported FCOI. Among studies with undisclosed FCOI, a mean of 18.8% (SD = 7.0%) of authors/study reported FCOI. The total dollar value of FCOIs was $1,974,328.3. The median conflict dollar value was $5,576.6 (IQR: $321.6 to $36,394.9). Conclusions We found a high burden of undisclosed FCOI (37.5%) among authors of propensity-score matched studies evaluating IBD biologics. Given the potential for undue industry influence stemming from such payments, authors should ensure better transparency with industry relationships. Funding Agencies None


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