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      Evidence for stratified conflicts of interest policies in research contexts: a methodological review

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          Abstract

          Objectives

          The purpose of this study was to conduct a methodological review of research on the effects of conflicts of interest (COIs) in research contexts.

          Design

          Methodological review.

          Data sources

          Ovid.

          Eligibility criteria

          Studies published between 1986 and 2021 conducting quantitative assessments of relationships between industry funding or COI and four target outcomes: positive study results, methodological biases, reporting quality and results–conclusions concordance.

          Data extraction and synthesis

          We assessed key facets of study design: our primary analysis identified whether studies stratified industry funding or COI variables by magnitude (ie, number of COI or disbursement amount), type (employment, travel fees, speaking fees) or if they assessed dichotomous variables (ie, conflict present or absent). Secondary analyses focused on target outcomes and available effects measures.

          Results

          Of the 167 articles included in this study, a substantial majority (98.2%) evaluated the effects of industry sponsorship. None evaluated associations between funding magnitude and outcomes of interest. Seven studies (4.3%) stratified industry funding based on the mechanism of disbursement or funder relationship to product (manufacturer or competitor). A fifth of the articles (19.8%) assessed the effects of author COI on target outcomes. None evaluated COI magnitude, and three studies (9.1%) stratified COI by disbursement type and/or reporting practices. Participation of an industry-employed author showed the most consistent effect on favourability of results across studies.

          Conclusions

          Substantial evidence demonstrates that industry funding and COI can bias biomedical research. Evidence-based policies are essential for mitigating the risks associated with COI. Although most policies stratify guidelines for managing COI, differentiating COIs based on the type of relationship or monetary value, this review shows that the available research has generally not been designed to assess the differential risks of COI types or magnitudes. Targeted research is necessary to establish an evidence base that can effectively inform policy to manage COI.

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          Most cited references41

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          Scoping studies: towards a methodological framework

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            Industry sponsorship and research outcome.

            Clinical research affecting how doctors practice medicine is increasingly sponsored by companies that make drugs and medical devices. Previous systematic reviews have found that pharmaceutical-industry sponsored studies are more often favorable to the sponsor's product compared with studies with other sources of sponsorship. A similar association between sponsorship and outcomes have been found for device studies, but the body of evidence is not as strong as for sponsorship of drug studies. This review is an update of a previous Cochrane review and includes empirical studies on the association between sponsorship and research outcome.
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              Association of funding and conclusions in randomized drug trials: a reflection of treatment effect or adverse events?

              Previous studies indicate that industry-sponsored trials tend to draw proindustry conclusions. To explore whether the association between funding and conclusions in randomized drug trials reflects treatment effects or adverse events. Observational study of 370 randomized drug trials included in meta-analyses from Cochrane reviews selected from the Cochrane Library, May 2001. From a random sample of 167 Cochrane reviews, 25 contained eligible meta-analyses (assessed a binary outcome; pooled at least 5 full-paper trials of which at least 1 reported adequate and 1 reported inadequate allocation concealment). The primary binary outcome from each meta-analysis was considered the primary outcome for all trials included in each meta-analysis. The association between funding and conclusions was analyzed by logistic regression with adjustment for treatment effect, adverse events, and additional confounding factors (methodological quality, control intervention, sample size, publication year, and place of publication). Conclusions in trials, classified into whether the experimental drug was recommended as the treatment of choice or not. The experimental drug was recommended as treatment of choice in 16% of trials funded by nonprofit organizations, 30% of trials not reporting funding, 35% of trials funded by both nonprofit and for-profit organizations, and 51% of trials funded by for-profit organizations (P<.001; chi2 test). Logistic regression analyses indicated that funding, treatment effect, and double blinding were the only significant predictors of conclusions. Adjusted analyses showed that trials funded by for-profit organizations were significantly more likely to recommend the experimental drug as treatment of choice (odds ratio, 5.3; 95% confidence interval, 2.0-14.4) compared with trials funded by nonprofit organizations. This association did not appear to reflect treatment effect or adverse events. Conclusions in trials funded by for-profit organizations may be more positive due to biased interpretation of trial results. Readers should carefully evaluate whether conclusions in randomized trials are supported by data.
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                Author and article information

                Journal
                BMJ Open
                BMJ Open
                bmjopen
                bmjopen
                BMJ Open
                BMJ Publishing Group (BMA House, Tavistock Square, London, WC1H 9JR )
                2044-6055
                2022
                19 September 2022
                : 12
                : 9
                : e063501
                Affiliations
                [1 ]departmentDepartment of Rhetoric & Writing , University of Texas at Austin , Austin, Texas, USA
                [2 ]departmentDepartment of English , The University of Texas at Austin , Austin, Texas, USA
                [3 ]departmentDepartment of Communication Studies , The Unviersity of Texas at Austin , Austin, TX, USA
                [4 ]departmentDepartment of Communication , North Dakota State University , Fargo, North Dakota, USA
                [5 ]departmentDepartment of Population Health and Neurology , The University of Texas at Austin Dell Medical School , Austin, Texas, USA
                Author notes
                [Correspondence to ] Dr S Scott Graham; ssg@ 123456utexas.edu
                Author information
                http://orcid.org/0000-0003-1569-2428
                http://orcid.org/0000-0001-8384-7175
                http://orcid.org/0000-0002-3851-4694
                http://orcid.org/0000-0002-2817-9124
                Article
                bmjopen-2022-063501
                10.1136/bmjopen-2022-063501
                9486359
                36123074
                3d11f125-d3b9-4225-93ef-f81ebc0b5fef
                © Author(s) (or their employer(s)) 2022. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.

                This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See:  http://creativecommons.org/licenses/by-nc/4.0/.

                History
                : 01 April 2022
                : 30 August 2022
                Funding
                Funded by: FundRef http://dx.doi.org/10.13039/100000002, National Institutes of Health;
                Award ID: R01GM141476
                Categories
                Ethics
                1506
                1693
                Original research
                Custom metadata
                unlocked

                Medicine
                health policy,statistics & research methods,ethics (see medical ethics),protocols & guidelines,risk management

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