Financial Conflicts Of Interest Disclosures Research Articles

Quality of content reporting on two major oncology media websites: OncLive and Targeted Oncology

IntroductionOncology media websites such as Oncology Live (OncLive) and Targeted Oncology (TargetedOnc) play an important role in the dissemination of oncology news to patients and clinicians; however, the quality of the content on these websites has not been assessed. Our study aimed to analyze content from these websites and assess financial conflicts of interest (FCOI) amongst speakers interviewed on these websites. MethodsArticles published on OncLive and TargetedOnc during October 2021, were prospectively captured and analyzed. The primary outcome of our study was the quality of oncology news reporting in OncLive and TargetedOnc. We assessed the FCOI amongst speakers using data from Open Payments. ResultsWe examined 196 articles (OncLive 108, TargetedOnc 88). Limitations of cited research were reported in 7% (7/105) of OncLive and zero TargetedOnc articles. Benefit and risks in absolute numbers were reported in 28% (28/99) of OncLive and 16% (7/45) of TargetedOnc articles. Independent experts were quoted in 47% (51/108) and 51% (44/86) of the OncLive and TargetedOnc articles, respectively (Table 3). Pharmaceutical executives were quoted in 18% (20/108) and 11% (10/88) of OncLive and TargetedOnc articles, respectively. No FCOI disclosures were listed or reported for any articles. The mean general payment received from industry by United States physicians was $63,861 in 2019 and $39,639 in 2020. ConclusionOur study demonstrates low quality and potentially biased reporting of oncology news on OncLive and TargetedOnc. Careful safeguards, oversight and reporting of relevant FCOI are needed to maintain the quality and transparency of content being provided.

Financial conflicts of interest of OncoAlert: An informal oncology professional network

ImportanceSocial media platforms have allowed the formation of informal professional healthcare networks. Transparency in funding, membership requirements, financial conflicts of interest (FCOI), and messaging are necessary to ensure best practices for similar networks in the future. ObjectiveTo analyze the FCOIs of US-based physician members of the OncoAlert Network and appraise the content of their public Twitter account. Design, setting, participantsThis cross-sectional study assessed the FCOIs among US-based physician members of the OncoAlert Network between 2015 and 2020. FCOI data were obtained through the Open Payments Database. Additionally, tweets were examined for content analysis. Main outcomes and measuresThe number of US-based physician members with FCOIs with the pharmaceutical industry; the amount of general, research, and associated research payments; and the perceived attitude of tweet content from the OncoAlert Network Twitter account. ResultsOf 34 US physician members of the OncoAlert Network, 31 (91.2%) received general payments from pharmaceutical companies according to the Open Payments Database. Between 2015 and 2020, US physician members of the OncoAlert Network received a median of $83,600 in general payments (interquartile range [IRQ], $7,200-$221,500). Fourteen members (41.1%) received more than $100,000 in general payments. Additionally, 480 (15.7 %) of 3064 tweets retrieved from the OncoAlert Twitter account mentioned a drug or clinical trial. Of these, 31.6 % (n = 152) had a positive disposition and 3.3 % (n = 16) were negative or critical. Conclusions and relevanceOver 90% of US physician members of the OncoAlert Network had FCOIs between 2015 and 2020. Despite the network’s non-profit status, FCOIs amongst its members may influence content produced on the network’s social media platforms, such as Twitter, where content discussing drugs and clinical trials are often positive and seldom negative or critical. For future informal professional networks, further research is required to establish best practices for issues such as membership requirements, funding, and FCOI disclosure.

Characteristics of oncology podcasts: Attitudes, speakers, conflicts

ObjectiveTo systematically appraise the content within oncology podcasts and the individuals who speak on them. DesignA cross-sectional study. SettingWe obtained a list of 33 current podcasts with substantial oncologic content through queries of predetermined search terms on the Apple Podcast Platform. Participants98 oncology-related podcast episodes. Main outcomesThe perceived attitude of the episode with predetermined categories including “Neutral,” “Favorable,” or “Negative,” the number of conflicts of interest verbally disclosed by individuals featured on oncology podcasts, and the prevalence of general payments among featured physicians. ResultsAmong 33 oncology podcasts, the median number of episodes was 81 (IQR: 25–129). Ninety-seven percent (n = 32/33) of the podcasts included guests. The median episode run time was 26:50 min (IQR: 18:00 – 41:75). Among the 98 episodes assessed, 47% of episodes (n = 46/98) mentioned oncologic drugs, of which 57% (n = 26) had a neutral disposition, 37% (n = 17) had a favorable disposition and 7% (n = 3) were negative. Across 98 episodes, we identified 194 featured individuals, of which 65% (n = 126) had a medical degree (MD), and 85% (n = 107/126) of these physicians received at least one general payment. Further, 83% (n = 105/126) of physicians did not disclose payments. Conclusions and policy summaryWithin oncology-related podcasts, the majority of conversations about oncologic drugs are perceived as either favorable or neutral, and a majority of individuals featured on podcasts do not disclose conflicts of interest, highlighting potential opportunities for improvement, including the need for standardization of financial conflict of interest disclosure.

Health Care Industry Payments to Editorial Board Members of Imaging-related Journals.

Background Editorial board members may be biased due to conflicts of interest (COIs). Purpose To investigate the frequency and amount of payments from industry to editorial board members of imaging-related journals and whether they are in agreement with the disclosure status as provided by the journal. Materials and Methods Editorial board members of 15 U.S.-based imaging-related journals who were listed in the Open Payments database (OPD) were included. Payments from industry to editorial board members in the year 2020 were extracted from the OPD and compared with publicly available COI disclosure data as provided by the journals. The Kruskal-Wallis test was used for statistical analysis. Results A total of 519 editorial board members were included, of whom 214 (41%) received industry payment and 305 (59%) did not. Payments to editorial board members by the industry ranged from $12.63 to $404 625.47 (median, $2397.48). Most payments from industry (59%) were ascribed to consulting. Editorial board members of the journals JACC: Cardiovascular Imaging and Journal of Vascular and Interventional Radiology received significantly higher amounts of individual payments from industry than editorial board members of most other journals. Financial COI disclosures were not publicly listed for 413 of the 519 (80%) editorial board members, 169 of whom received payments from industry according to the OPD. Of the 106 editorial board members whose financial COI disclosures were publicly listed, 36 (34%) were discordant with the OPD. Conclusion Payments from industry to Open Payments database-listed editorial board members of imaging-related journals are prevalent. Imaging-related journals often do not report or do not accurately report payments from industry to their editorial board members © RSNA, 2022.

Improving financial disclosures in oncology.

e18642 Background: The Physician Payments Sunshine Act, as part of the Affordable Care Act, was enacted in 2010 to improve transparency of payments from drug and medical device manufacturers to physicians, which are easily accessible in a public database (OpenPayments CMS). However, in a review conducted of clinical drug trials in oncology, one-third of oncologist authors did not disclose their industry payments. Failure to disclose financial conflicts of interest can lead to a loss of public trust and in some cases may lead to legal liability. The American Society for Clinical Oncology and our institutional polices require all faculty to fully report financial conflicts of interest (COI). This pilot project aims to evaluate the accuracy of financial COI disclosures among our oncologists at the University of Chicago, and improve subsequent disclosures. Methods: This project was approved through the institutional quality improvement process. In May 2020, we crossmatched COI disclosures on journal publications for 37 practicing clinical hematologists/oncologists in our institution with 2017 and 2018 records on OpenPayments. We then conducted a department-wide Grand Rounds to review omissions, and to remind faculty of ASCO and University COI policies. In addition, we privately contacted individual oncologists to review any COI omissions. We reminded faculty that at the end of 2020 we would again review the accuracy of their disclosures. Results: We examined a total of 37 practicing hematologists/oncologists’ disclosure forms. At initial review, 6/37 (16.2%) of oncologists had incomplete or missing disclosures. A total of $569,182.95 in payments was not disclosed in 2018. 2 of these 6 oncologists did not disclose relevant payments from pharmaceutical companies whose drugs were referred to in publications. Several disclosure errors appeared to be inadvertent omissions as they were disclosed in other publications. Reasons given for disclosure omissions were: “oversight”, “did not believe to be relevant to publication”, “confusion over journal COI policies”, “unnecessary due to low payment amount”, "too many journals to update disclosures in". At the final review, only 2 of the 6 oncologists with disclosure omissions had updated disclosures at the end of the year despite education provided at multiple grand rounds and private communications. Conclusions: This pilot project demonstrated that education sessions and individual feedback improved adherence to COI disclosure policies, but not fully. Additional feedback and enforcement mechanisms may be required for full compliance. In addition, a centralized disclosure form (such as ASCO’s disclosure form) that journals can easily access may improve disclosure adherence.

Discrepancies in self-reported financial conflicts of interest disclosures by physicians: a systematic review

BackgroundThere is a high prevalence of financial conflicts of interest (COI) between physicians and industry.ObjectivesTo conduct a systematic review with meta-analysis examining the completeness of self-reported financial COI disclosures by...

Financial Conflicts of Interest in Clinical Practice Guidelines: A Systematic Review.

ObjectiveTo systematically evaluate the prevalence of disclosed and undisclosed financial conflicts of interest (FCOI) among clinical practice guidelines (CPGs).MethodsIn this systematic review, we ascertained the prevalence and types of FCOI for CPGs from January 1, 1980, to March 3, 2019. The primary outcome was the prevalence of FCOI among authors of CPGs. FCOI disclosures were compared between medical subspecialties and societies producing CPGs.ResultsAmong the 37 studies including 14,764 total guideline authors, 45% had at least one FCOI. The prevalence of FCOI per study ranged from 6% to 100%. More authors had FCOI involving general payments (39%) compared with research payments (29%). Oncology, neurology, and gastroenterology had the highest prevalence of FCOI compared with other medical specialties. Among the 8 studies that included the monetary values in US dollars of FCOI, average payments per author ranged from $578 to $242,300. Among the 10 studies that included data on undisclosed FCOI, 32% of authors had undisclosed industry payments.ConclusionThere are numerous FCOI among authors of CPGs, many of which are undisclosed. Our study found a significant difference in FCOI prevalence based on types of FCOI and CPG sponsor society. Additional research is required to quantify the implications of FCOI on clinical judgment and patient care.

Self-reported Financial Conflict of Interest in Nephrology Clinical Practice Guidelines

IntroductionThere is ongoing controversy concerning the potential influence of industry and financial conflict of interest (FCOI) in the development of clinical practice guidelines (CPG). The influence of industry in renal guideline development has been discussed in the past with emphasis on the National Kidney foundation (NKF) and Kidney and Dialysis Outcomes Quality Initiative guidelines. In this study we evaluate the self-reported FCOI among guideline panel members in Kidney Disease: Improving Global Outcomes (KDIGO) CPGs.MethodsWe examined 10 of the most recent KDIGO CPGs developed between 2009 and 2018. Using disclosure lists, we catalogued FCOIs for panelists for each individual CPG. The categories were Advisor/Consultant, Honoraria, Travel Stipend, Grant/Research Support, Speaker, Equity Interest, Employee, Board of Trustees, Royalties, Advisory Board, Employment, Ownership, Data Monitoring Committee, Expert Testimony, and Development of Education Materials. We also reviewed FCOIs for members of evidence review team (ERT). We also catalogued the company involved in each disclosure. One conflict describes 1 instance of participation of an individual in 1 category in each guideline. “Company” describes a commercial, industry, or institute affiliation reported in each episode.ResultsOne hundred two (66.4%) of the total 151 panelists reported FCOI. A total of 662 conflicts were disclosed. Being a consultant or advisor was the most common category. One hundred fifty-one companies were associated with FCOI disclosure. One company was most frequently reported, involving 60 (9%) of 662 conflicts. Of the 52 members in the ERT, there was 1 instance of FCOI.ConclusionFCOI is prevalent in KDIGO guidelines with almost two thirds of the panelists self-reporting FCOI. The evidence review team had only 1 instance of FCOI.

Pharmaceutical company payments to dermatology Clinical Practice Guideline authors in Japan.

Clinical Practice Guidelines (CPGs) play significant roles in most medical fields. However, little is known about the extent of financial Conflicts of Interest (FCOIs) related to pharmaceutical companies (Pharma) selling dermatology prescription products and dermatology CPG authors in Japan. The aims of this study were to elucidate the characteristics and distribution of payments from Pharma to dermatology CPG authors in Japan, and to evaluate the extent of transparency and accuracy in their FCOI disclosures. We analyzed the records of 296 authors from 32 dermatology CPGs published by the Japanese Dermatological Association from the beginning of 2015 to the end of 2018. Using the payment data reported by 79 Pharma between 2016-2017 in Japan, we investigated the characteristics of the CPG authors and the payments from the Pharma to them. Furthermore, we evaluated the transparency and accuracy of the FCOI disclosures of the individual CPG authors. Of the 296 CPGs authors, 269 authors (90.6%) received at least one payment from the Pharma. The total monetary value of payments for the 2-year period was $7,128,762. The median and mean monetary value of payments from the Pharma reporting were $10,281 (interquartile range $2,796 -$34,962) and $26,600 (standard deviation $40,950) for the two years combined. Of the 26 CPG authors who disclosed FCOIs due to the monies received from Pharma, only the atopic dermatitis CPG authors and the acne vulgaris CPG authors published their potential FCOIs. In Japan, most dermatology CPG authors received financial payments from Pharma. The transparency of the CPGs, as reported by the CPG authors, was inadequate, and a more rigorous framework of reporting and monitoring FCOI disclosure is required to improve the accuracy and transparency with relation to possible Conflicts of Interest.

Pharmaceutical Company Payments to Japanese Government Drug Regulation Committee Members.

Little is known about the characteristics and distribution of financial conflicts of interest (FCOIs) in the drug regulation process, both in Japan and globally. This study aimed to identify the characteristics and distribution of pharmaceutical payments to members of Japanese government drug regulation committees, and to assess the accuracy of their FCOI statements. Among members who worked for either of the five committees of the Pharmaceutical Affairs and Food Sanitation Council (PAFSC), which is the advisory committee for pharmaceutical affairs in Japan, from April 1, 2017 to March 31, 2019, the extent of payments in 2016 from 78 major pharmaceutical companies in Japan and the accuracy of the self-reported FCOI disclosures were assessed. Of 108 members, 54 (50%) were medical doctors. The payments to the PAFSC members totaled ¥115,765,006 ($1,064,017), and the mean (SD) payment was ¥1,071,898 ($9,852) (¥2,272,520 ($20,887)). Fifty-one members (47%) received at least one payment from a pharmaceutical company in 2016; 32 members (30%) received more than ¥500,000 ($4,600). Of 8,530 declarations from five councils, 409 (4.8%) of the FCOIs self-reported by the committee members were inaccurate. Of those inaccurate disclosures, 112 of 409 inaccurate disclosures (27.4%) would have prevented the recipients from participating in the drug-approval decision-making processes had they been correctly disclosed. Almost half of drug regulation committee members in Japan received at least one payment from pharmaceutical companies in 2016. Moreover, several FCOIs they reported were inaccurate.

Authors of clinical trials seldom reported details when declaring their individual and institutional financial conflicts of interest: a cross-sectional survey

BackgroundThe main objective of this study was to document details of both individual and institutional financial conflicts of interest (FCOIs) reported by the authors of clinical trials. An additional objective was to assess the predictors of having at least one author reporting any FCOI. MethodsWe used a sample of randomized controlled trials from a previous cross-sectional survey and included the trials, which reported at least one FCOI disclosure. We categorized the types of disclosed FCOI as grant, employment income, personal fees, nonmonetary support, drug or equipment supplies, patent, stocks, and other types. We collected data on the characteristics of the included RCTs, of the authors, and of the reported FCOI disclosures. We conducted descriptive analyses and a regression analysis to assess the predictors of having at least one author reporting any FCOI. ResultsAll 108 included RCTs reported being funded, with 58% reporting funding by a private-for-profit source. Out of 1,687 authors, 814 (48%) reported at least one, and a median of 2, FCOI disclosures. Of the 814 reporting disclosures, far more reported individual FCOIs (99%) than institutional FCOIs (6%). The most commonly reported individual FCOI subtypes were grant (49%), personal fees (48%), and employment income (22%). Of the 99% of disclosures that included the source of FCOI, a private-for-profit entity provided the funds in 85%. Reporting about the relation of the FCOI source's to the product investigated in the trial, the timing of FCOI, and monetary value of FCOI was limited. Reporting of FCOIs proved most strongly associated with author affiliation being an academic institution (OR = 2.981; 95% CI: 2.415-3.680) and trial funding from entity other than a private-for-profit entity (OR = 2.809; 95% CI: 2.274-3.470). ConclusionApproximately half of the trial authors report individual FCOIs, often three or more, but seldom provide details related to source's relation to the trial, or the timing and monetary value of the FCOI.

Financial conflicts of interest among National Comprehensive Cancer Network clinical practice guideline panelists in 2019.

Clinical practice guidelines (CPGs) are evidence-based guidelines that serve as a standard of care in oncology practice, reimbursements, and quality improvement initiatives. To our knowledge, the extent of financial conflicts of interest (FCOIs) in National Comprehensive Cancer Network (NCCN) guidelines have not been systemically evaluated. The current study evaluated the extent of FCOIs in the NCCN CPGs for the most common malignancies in the United States. The authors examined the latest 2019 versions of the NCCN CPGs for the 10 most common cancers by incidence in the United States. Using disclosure lists, they catalogued the FCOIs for the panelists under various categories outlined in the CPG. The authors also tabulated the companies and institutions involved in each panel disclosure. An "episode" describes 1 instance of participation of a panelist in 1 company in 1 category of each guideline. "Affiliation" describes an industrial, commercial, or institutional affiliation reported by a panelist in each episode. Of the 491 panelists on the CPG panel, 483 (98.3%) completed FCOI disclosures. A total of 224 (46.4%) reported at least 1 FCOI episode. A total of 1103 episodes were disclosed with an average of 4.9 episodes reported per panelist with FCOIs. Acting as part of scientific advisory boards, as a consultant, or as an expert witness was the most common FCOI category (19.9%). A total of 191 companies were associated with 1103 episodes of FCOI. The top companies were Bristol-Myers Squibb, Merck, Genentech, and AstraZeneca. Among cancers, the prevalence of FCOIs was highest for lung cancer (56%), bladder cancer (52%), pancreatic cancer (52%), non-Hodgkin lymphoma (50%), kidney cancer (49%), colorectal cancer (43%), breast cancer (42%), melanoma (40%), prostate cancer (38%), and uterine cancer (32%). Among the panelists with FCOIs, 26%, 17%, and 57%, respectively, reported 1, 2, and >3 episodes. There were 127 episodes noted among the CPG chairs and/or vice chairs who reported FCOIs (mean, 6.4 episodes). The chairs and/or vice chairs of CPGs for uterine cancer, pancreatic cancer, melanoma, and prostate cancer were not found to have any FCOIs. FCOIs are very prevalent among NCCN CPG panelists. In nearly one-half of the CPGs, the majority of the panelists had at least 1 FCOI. Greater than one-half of the CPG chairs and/or vice chairs reported multiple FCOIs. Further research studies are necessary to determine the impact of these FCOIs.

Financial conflicts of interest among the National Comprehensive Cancer Network (NCCN) Clinical Practice Guideline (CPG) Panelists in 2019.

15 Background: CPG are evidence-based guidelines, which serve as a standard of care in practice, quality improvement, and reimbursement. The extent of financial conflicts of Interest (FCOI) in NCCN guidelines has not been recently evaluated. Our study evaluated the extent of FCOI in the NCCN CPG among the 10 most common malignancies in the US. Methods: We examined the latest 2019 version of the NCCN CPG for the 10 most common cancers by incidence in the US. Using disclosure lists, we catalogued the FCOIs for the panelists under various categories outlined in the CPG. We also tabulated the companies/institutions involved in each disclosure. An “episode” describes 1 instance of participation of a panelist in 1 company in 1 category of each guideline. “Affiliation” describes a commercial, industry, or institute affiliation reported by a panelist in each episode. Results: Of the 491 panelists on the CPG, 483 (98.3%) completed FCOI disclosures. 224 (46.38%) reported at least 1 FCOI. A total of 1,103 episodes were disclosed with an average of 4.9 episodes per panelist with FCOI. Being a part of scientific advisory boards, consultant, or expert witness was the most common FCOI category (19.9%). A total of 191 companies were associated with 1,103 episodes of FCOI. The top companies were Bristol Myers Squibb, Merck, Genentech and AstraZeneca. Among the top 10 cancers, the prevalence of FCOI were lung (56%), bladder (52%), pancreatic (52%), non-Hodgkin lymphoma (50%), kidney (49%), colorectal (43%), breast (42%), melanoma (40%), prostate (38%), and uterine (32%). Among the panelists with FCOI, 26%, 17%, and 57% reported 1, 2, and > 3 episodes, respectively. There were 127 episodes among the CPG chairs/vice chairs who reported FCOI (mean 6.4). The chairs/vice chairs of uterine, pancreatic, melanoma, and prostate cancer CPG did not have any FCOI. Conclusions: FCOI are very prevalent among the top 10 NCCN CPG panelists. In almost half of the CPG, the majority of the panelists had at least 1 FCOI. Over half of the CPG chairs/vice chairs reported multiple FCOI. Further studies are necessary to determine the impact of these FCOI.

Discordant financial conflicts of interest disclosures between clinical trial conference abstract and subsequent publication.

BackgroundFinancial conflicts of interest (FCOI) are known to be prevalent in medicine. Authorship of pivotal trials reap non-financial benefits including publication productivity that can be used for assessment of tenure positions and promotion. The purpose of this investigation was to quantify the prevalence and discordance of academic trial author (authors) FCOI in industry-sponsored drug trials that were initially presented as oral abstracts and subsequently resulted in a peer-reviewed publication.MethodsOral abstracts from the American Society of Clinical Oncology (ASCO) 2017 Annual Meeting that were subsequently published were identified. Studies that were non-industry sponsored, non-adult, or non-therapeutic trials were excluded. Studies that did not have a subsequent peer-reviewed publication or had a publication preceding the ASCO 2017 Annual Meeting were also excluded. FCOI was categorized and impact factor (IF) for the journal at the time of publication was retrieved. FCOI discordance between the oral abstract and publication was calculated based on geographic location and IF.ResultsA total of 22 paired abstract and publications met inclusion criteria for further analysis. A total of 384 authors were identified, of these 280 authors (74.1%) were included in both the oral abstract and subsequent publication. A total of 76% of these 280 authors had FCOI and 66.4% had FCOI discordance. There were statistically significant differences for the sum of FCOI discordance for U.S.-based authors (p = 0.0004) but not for journal IF. When analyzing the sum of absolute differences of FCOI discordance, statistical significance was reached for authors from any of the three geographic regions, as well as, low and high IF journals (all p-values < 0.0001).ConclusionsThis study draws attention to the lack of uniformity and vetting of FCOI reporting in abstracts and journals publishing solid tumor oncology trial results. This is particularly concerning, since FCOI is prevalent globally.

Financial Conflicts of Interest in Inflammatory Bowel Disease Guidelines.

Industry payments can lead to financial conflicts of interest (FCOI) among authors of clinical practice guidelines (CPGs). Guidelines for inflammatory bowel disease (IBD) may be at particularly high risk. We determined the prevalence of FCOI in IBD CPGs produced by various gastroenterology societies. We conducted a cross-sectional analysis of FCOI disclosure among CPGs related to the management of IBD. We ascertained the prevalence and types of FCOI for each guideline and determined adherence to National Academy of Medicine (NAM) standards. FCOI disclosures were compared between societies producing CPGs. We identified 11 relevant CPGs with 173 total authors. There were 117 (68%) authors who declared a payment. A total of 107 (62%) authors declared FCOI related to a medication recommended in the guideline. There was a significant difference (P < 0.001) between the proportion of authors with FCOI between countries or regions. Authors of US CPGs had a significantly lower FCOI prevalence (19%) compared with other societies. Authors of UK CPGs had a significantly lower FCOI prevalence (56%) compared with Canadian (84%) and European (94%) CPGs. Three (27%) guidelines adhered to both NAM standards. A substantial portion of authors of IBD CPGs had FCOI. Our study found a significant difference in FCOI prevalence based on CPG sponsor nationality. Most CPGs for IBD did not adhere to NAM standards for FCOI disclosure.

Public health journals\u2019 requirements for authors to disclose funding and conflicts of interest: a cross-sectional study

BackgroundPublic health journals need to have clear policies for reporting the funding of studies and authors’ personal financial and non-financial conflicts of interest (COI) disclosures. This study aims to assess the policies of public health journals on reporting of study funding and the disclosure of authors’ COIs.MethodsThis is a cross-sectional study of “Public, Environmental & Occupational Health” journals. Teams of two researchers abstracted data in duplicate and independently using REDCap software.ResultsOf 173 public health journals, 155 (90%) had a policy for reporting study funding information. Out of these, a majority did not require reporting of the phase of the study for which funding was received (88%), nor the types of funding sources (87%). Of the 173 journals, 163 (94%) had a policy requiring disclosure of authors’ COI. However, the majority of these journals did not require financial conflicts of interest disclosures relating to institutions (75%) nor to the author’s family members (90%) while 56% required the disclosure of at least one form of non-financial COI.ConclusionsThe policies of the majority of public health journals do not require the reporting of important details such as the role of the funder, and non-financial COI. Journals and publishers should consider revising their editorial policies to ensure complete and transparent reporting of funding and COI.

Transparency ethics in practice: Revisiting financial conflicts of interest disclosure forms in clinical practice guidelines.

BackgroundAuthors of clinical practice guidelines (CPGs) disclose financial conflicts of interest (FCOIs) to promote transparency ethics. Typically, they do so on standard declaration forms containing generic open-ended questions on FCOIs. Yet, the literature is scant on the format and effect of alternative disclosure forms. Does supplementing a standard form with subsequent detailed disclosure forms tailored to the context of the CPG improve the yield or accuracy of FCOIs declarations?MethodsFor an international CPG in gastroenterology on the endoscopic surveillance for colorectal neoplasia in inflammatory bowel disease, we compared the use of a standard FCOIs disclosure form with a contextual FCOIs disclosure form that detailed commercial relations related to the CPG topic. This included manufacturers of endoscopes, endoscopy equipment and accessories. Participants completed the generic form early, and the supplementary contextual form six months later. We then compared the FCOI disclosures obtained.Findings26 participants provided FCOIs disclosures using both disclosure forms. We found discrepancies regarding (1) the disclosure of FCOIs (presence/absence), and (2) the listing of financial entities. While the number of participants who disclosed a FCOI remained the same (30.8%) using the two forms, disclosures were not from the same individuals: two additional participants disclosed a FCOI, whereas two participants withdrew previous disclosures. Among those who reported a FCOI in either form, we noted inconsistencies in disclosures for 70% of the participants. This included changes in FCOIs disclosure status or modifications of "their commercial relations".DiscussionAccurate reporting of FCOIs advances the transparency and ethical integrity of CPGs. Our experience suggests that a contextual FCOIs disclosure form tailored to content of the CPG with narrow, detailed questions provides supplementary, more complete FCOIs declarations than generic forms alone. The finding raises challenges on how forms are best written and formatted, optimally timed, and more effectively processed with sensitivity to professional behaviour, so as to heighten transparency.

ACPA 2017 Oral Presentation Abstracts

The peer-reviewed abstracts presented at the 74th Annual Meeting of the ACPA are published as submitted by the authors. For financial conflict of interest disclosure, please visit http://meeting.acpa-cpf.org/disclosures.html.

Legislative Issues in Disclosing Financial Conflicts of Interest to Participants in Biomedical Research: Effectiveness and Methodology.

This research focuses on the analysis regarding disclosure of financial conflicts of interest (FCOI) after Gelsinger v. University of Pennsylvania (Penn). The main legal issue was that the participants did not have enough opportunity to make an autonomous decision about participating in the research because he was not informed about the researchers' and the institution's substantial FCOI. The disclosure system was adopted by the Code of Federal Regulations. Under the regulation, researchers and institutions need to report FCOI over $5,000 to the institution, and the internal review boards have to report to the federal authority if needed. In case of human research, the disclosure to Food and Drug Administration is mandatory. FCOI disclosure system would help participants to make an autonomous decision, and increase trust to the research process and researchers. Moreover, the system would let researchers keep fiduciary duty while (possibly) lowering legal liability in case of a lawsuit. There were discussions about the disclosure methodology in the United States. However, there have not been a lot of discussions in Korea even after the “Humidifier Disinfectant” case. Therefore, new legislations need to be considered. First, the system requires disclosure funded by not only government but also private institutions. Second, like California Supreme Court, the subject would be reviewed under the reasonable person standard by participants, including patents, equity, and stock. Third, the disclosure needs to include simple or brief explanation to the FCOI to be better understood by the participants. Fourth, the disclosure should be in the informed consent process.

Reporting of financial conflicts of interest in clinical practice guidelines: a case study analysis of guidelines from the Canadian Medical Association Infobase.

BackgroundClinical practice guidelines are widely distributed by medical associations and relied upon by physicians for the best available clinical evidence. International findings report that financial conflicts of interest (FCOI) with drug companies may influence drug recommendations and are common among guideline authors. There is no comparable study on exclusively Canadian guidelines; therefore, we provide a case study of authors’ FCOI declarations in guidelines from the Canadian Medical Association (CMA) Infobase. We also assess the financial relationships between guideline-affiliated organizations and drug companies.MethodsUsing a population approach, we extracted first-line drug recommendations and authors’ FCOI disclosures in guidelines from the CMA Infobase. We contacted the corresponding authors on guidelines when FCOI disclosures were missing for some or all authors. We also extracted guideline-affiliated organizations and searched each of their websites to determine if they had financial relationships with drug companies.ResultsWe analyzed 350 authors from 28 guidelines. Authors were named on one, two, or three guidelines, yielding 400 FCOI statements. In 75.0 % of guidelines at least one author, and in 21.4 % of guidelines all authors, disclosed FCOI with drug companies. In 54.0 % of guidelines at least one author, and in 28.6 % of guidelines over half of the authors, disclosed FCOI with manufacturers of drugs that they recommended. Twenty of 48 authors on multiple guidelines reported different FCOI in their disclosures. Eight guidelines identified affiliated organizations with financial relationships with manufacturers of drugs recommended in those guidelines.ConclusionsThis is the first study to systematically describe FCOI disclosures by authors of Canadian guidelines and financial relationships between guideline-affiliated organizations and pharmaceutical companies. These financial relationships are common. Because authoritative value is assigned to guidelines distributed by medical associations, we encourage them to develop formal policies to limit the potential influence of FCOI on guideline recommendations.Electronic supplementary materialThe online version of this article (doi:10.1186/s12913-016-1646-5) contains supplementary material, which is available to authorized users.