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Investigator experiences with financial conflicts of interest in clinical trials.

ABSTRACT: Financial conflicts of interest (fCOI) can introduce actions that bias clinical trial results and reduce their objectivity. We obtained information from investigators about adherence to practices that minimize the introduction of such bias in their clinical trials experience.Email survey of clinical trial investigators from Canadian sites to learn about adherence to practices that help maintain research independence across all stages of trial preparation, conduct, and dissemination. The main outcome was the proportion of investigators that reported full adherence to preferred trial practices for all of their trials conducted from 2001-2006, stratified by funding source.844 investigators responded (76%) and 732 (66%) provided useful information. Full adherence to preferred clinical trial practices was highest for institutional review of signed contracts and budgets (82% and 75% of investigators respectively). Lower rates of full adherence were reported for the other two practices in the trial preparation stage (avoidance of confidentiality clauses, 12%; trial registration after 2005, 39%). Lower rates of full adherence were reported for 7 practices in the trial conduct (35% to 43%) and dissemination (53% to 64%) stages, particularly in industry funded trials. 269 investigators personally experienced (n = 85) or witnessed (n = 236) a fCOI; over 70% of these situations related to industry trials.Full adherence to practices designed to promote the objectivity of research varied across trial stages and was low overall, particularly for industry funded trials.

SUBMITTER: Rochon PA

PROVIDER: S-EPMC3031202 | biostudies-literature | 2011 Jan

REPOSITORIES: biostudies-literature

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Investigator experiences with financial conflicts of interest in clinical trials.

Rochon Paula A PA Sekeres Melanie M Hoey John J Lexchin Joel J Ferris Lorraine E LE Moher David D Wu Wei W Kalkar Sunila R SR Van Laethem Marleen M Gruneir Andrea A Gold Jennifer J Maskalyk James J Streiner David L DL Taback Nathan N Chan An-Wen AW

Trials 20110112

<h4>Background</h4>Financial conflicts of interest (fCOI) can introduce actions that bias clinical trial results and reduce their objectivity. We obtained information from investigators about adherence to practices that minimize the introduction of such bias in their clinical trials experience.<h4>Methods</h4>Email survey of clinical trial investigators from Canadian sites to learn about adherence to practices that help maintain research independence across all stages of trial preparation, condu ...[more]

PMID: 21226951

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Project description: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.

Project description: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.

Project description:ObjectiveTo characterise and analyse the experiences of trial researchers of if and how conflicts of interest had unduly influenced clinical trials they had worked on, what management strategies they had used to minimise any potential influence, and their experiences and views on conflicts of interest more generally.DesignQualitative interview study.ParticipantsTrial researchers who had participated in at least 10 clinical trials with methodological or statistical expertise. Researchers differed by geographical location, educational background, and experience with different types of funders. Interviewees were identified by searches on Web of Science and snowball sampling. 52 trial researchers were approached by email; 20 agreed to be interviewed.SettingInterviews conducted by telephone, recorded, transcribed verbatim, imported to NVivo 12, and analysed by systematic text condensation. Semistructured interviews focused on financial and non-financial conflicts of interest.ResultsThe interviewees had participated in a median of 37.5 trials and were mainly male physicians who had experience with commercial and non-commercial trial funders. Two predefined themes (influence of conflicts of interest and management strategies) and two additional themes (definition and reporting of conflicts of interest) emerged. Examples of perceived influence of conflicts of interest were: choice of inferior comparator, manipulation of the randomisation process, prematurely stopping the trials, fabrication of data, blocking access to data, and spin (eg, overly favourable interpretation of the results). Examples of strategies to manage conflicts of interest were: disclosure procedures, exclusion of the funder from design and analysis, independent committees, contracts ensuring complete access to the data, and no restriction by the funder on analysis and reporting. Interviewees used different definitions or thresholds for what they considered to be conflicts of interest, and they described different criteria for when to report them. Some interviewees considered non-commercial financial conflicts of interest (eg, funding of trials by governmental health agencies with a political agenda) to be equally or more important than commercial financial conflicts of interest (eg, funding by drug and device companies), but more challenging to report and manage.ConclusionThis study described how trial researchers perceive conflicts of interest unduly influencing clinical trials they had worked on, and the management strategies they used to prevent these influences. The results indicated considerable variability in researchers' understanding of what conflicts of interest are and when they should be reported.

Project description:Background. Tobacco companies have actively promoted the substitution of cigarettes with purportedly safer tobacco products (e.g., smokeless tobacco, e-cigarettes) as tobacco harm reduction (THR). Given the tobacco, e-cigarette, and pharmaceutical industries' substantial financial interests, we quantified industry influence on support for THR. Objectives. To analyze a comprehensive set of articles published in peer-reviewed journals assessing funding sources and support for or opposition to substitution of tobacco or nicotine products as harm reduction. Search Methods. We searched PubMed, Embase, Web of Science, and PsycINFO with a comprehensive search string including all articles, comments, and editorials published between January 1, 1992, and July 26, 2016. Selection Criteria. We included English-language publications published in peer-reviewed journals addressing THR in humans and excluded studies on modified cigarettes, on South Asian smokeless tobacco variants, on pregnant women, on animals, not mentioning a tobacco or nicotine product, on US Food and Drug Administration-approved nicotine replacement therapies, and on nicotine vaccines. Data Collection and Analysis. We double-coded all articles for article type; primary product type (e.g., snus, e-cigarettes); themes for and against THR; stance on THR; THR concepts; funding or affiliation with tobacco, e-cigarette, pharmaceutical industry, or multiple industries; and each author's country. We fit exact logistic regression models with stance on THR as the outcome (pro- vs anti-THR) and source of funding or industry affiliation as the predictor taking into account sparse data. Additional models included article type as the outcome (nonempirical or empirical) and industry funding or affiliation as predictor, and stratified analyses for empirical and nonempirical studies with stance on THR as outcome and funding source as predictor. Main Results. Searches retrieved 826 articles, including nonempirical articles (21%), letters or commentaries (34%), editorials (5%), cross-sectional studies (15%), systematic reviews and meta-analyses (3%), and randomized controlled trials (2%). Overall, 23.9% disclosed support by industry; 49% of articles endorsed THR, 42% opposed it, and 9% took neutral or mixed positions. Support from the e-cigarette industry (odds ratio [OR]?=?20.9; 95% confidence interval [CI]?=?5.3, 180.7), tobacco industry (OR?=?59.4; 95% CI?=?10.1, +infinity), or pharmaceutical industry (OR?=?2.18; 95% CI?=?1.3, 3.7) was significantly associated with supportive stance on THR in analyses accounting for sparse data. Authors' Conclusions. Non-industry-funded articles were evenly divided in stance, while industry-funded articles favored THR. Because of their quantity, letters and comments may influence perceptions of THR when empirical studies lack consensus. Public Health Implications. Public health practitioners and researchers need to account for industry funding when interpreting the evidence in THR debates.

Project description:Background There is a high prevalence of financial conflicts of interest (COI) between physicians and industry. Objectives To conduct a systematic review with meta-analysis examining the completeness of self-reported financial COI disclosures by physicians, and identify factors associated with non-disclosure. Data sources MEDLINE, Embase and PsycINFO were searched for eligible studies up to April 2020 and supplemented with material identified in the references and citing articles. Data extraction and synthesis Data were independently abstracted by two authors. Data synthesis was performed via systematic review of eligible studies and random-effects meta-analysis. Main outcomes and measures The proportion of discrepancies between physician self-reported disclosures and objective payment data was the main outcome. The proportion of discrepant funds and factors associated with non-disclosure were also examined. Results 40 studies were included. The pooled proportion of COI discrepancies at the article level was 81% (range: 54%–98%; 95% CI 72% to 89%), 79% at the payment level (range: 71%–89%; 95% CI 67% to 89%), 93% at the authorship level (range: 71%–100%; 95% CI 79% to 100%) and 66% at the author level (range: 8%–99%; 95% CI 48% to 78%). The proportion of funds discrepant was 33% (range: 2%–77%; 95% CI 12% to 58%). There was high heterogeneity between studies across all five analyses (I2=94%–99%). Most undisclosed COI were related to food and beverage, or travel and lodging. While the most common explanation for failure to disclose was perceived irrelevance, a median of 45% of non-disclosed payments were directly or indirectly related to the work. A smaller monetary amount was the most common factor associated with nondisclosure. Conclusions Physician self-reports of financial COI are highly discrepant with objective data sources reporting payments from industry. Stronger policies are required to reduce reliance on physician self-reporting of financial COI and address non-compliance.

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Investigator experiences with financial conflicts of interest in clinical trials.

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Investigator experiences with financial conflicts of interest in clinical trials.

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