The association between funding by commercial interests and study outcome in randomized controlled trials
Department of Social Medicine, Hadassah Medical Center, Yerushalayim, Jerusalem, Israel Family Practice
(Impact Factor: 1.86).
12/2001; 18(6):565-8. DOI: 10.1093/fampra/18.6.565
Previous studies limited to specific drugs or journal types have shown an association between the source of funding of research and the published results.
The aim of the present study was to determine the association between source of support of research and published outcomes of randomized controlled drug trials in general interest medical journals.
Randomized controlled drug trials (n = 314) published in five general interest medical journals over a 2-year period were reviewed. Study outcome was classified as positive or negative. Support was classified as pharmaceutical industry or non-industry. Association between source of support and outcome was tested with the chi-squared statistic.
Positive findings were found in 77% of studies, negative findings in 20% and an uncertain outcome in 3%. Support from commercial sources was found in 68% of trials. Negative findings were found in 13% of industry-supported studies and in 35% of non-industry-supported studies (chi-squared = 18.36, P < 0.0001, odds ratio = 3.54, 95% confidence interval 1.90-6.62).
An association was found between the source of study support and the published outcome. Though the reason for this association cannot be determined from the data collected, future studies may clarify the importance of this finding for readers concerned with the relationship of funding bodies to the publication of research outcomes.
Available from: Francesc Roig
- "El 96% de los autores que apoyaban los bloqueadores de los canales de calcio tenían relaciones económicas con los productores de estos fármacos, comparado con el 60% de los autores que se mostraban " neutrales " y el 37% de los que se mostraban críticos. Con posterioridad, han sido numerosos los estudios que han documentado una asociación entre conflictos de interés y conclusiones " pro-industria " , especialmente en ensayos clínicos aleatorizados (Yaphe y otros, 2001; Kjaergard y Als-Nielsen, 2002; Als- Nielsen y otros, 2003; Montgomery y otros, 2004; 3 Perlis y otros, 2005; Ridker y Torres, 2006; Etter y otros, 2007; Peppercorn y otros, 2007; Tungaraza y Poole, 2007; Bero y otros, 2007). "
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ABSTRACT: Resumen: Los vínculos profesionales y financieros entre la industria farmacéutica y las personas e instituciones que llevan a cabo investigación, formación y práctica médicas pueden provocar que intereses individuales o corporativos influyan en la toma de decisiones y en el juicio profesional. Esta situación de posible conflicto de intereses amenaza la integridad de la investigación, la objetividad de la educación médica, la calidad de la atención al paciente y, de forma más general, la confianza pública en la medicina. Una estrategia para proteger la integridad de la investigación y mantener la confianza pública es la comunicación de los posibles conflictos de interés de los autores cuando publican los resultados en las revistas científicas. El presente trabajo analiza las políticas editoriales de declaración de conflictos de interés de las 16 revistas de orientación clínica publicadas en España incluidas en el JCR del año 2011. Los resultados ponen de manifiesto que la mayoría de revistas incluyen en sus instrucciones para autores al menos una mención a la necesidad de declarar los conflictos de interés y ofrecen algún tipo de descripción de estas situaciones, si bien se trata de definiciones laxas sobre las relaciones económicas que se deben declarar, y sin que especifiquen el alcance de las relaciones personales. En la mayor parte de los casos no existen formularios estándar de declaración de conflictos de interés, no se determina el tiempo durante el que puede considerarse que una relación es susceptible de generarlo, no se indica quién y cómo evaluará las declaraciones, ni se indica si las declaraciones se publicarán en los artículos.
Palabras clave: Biomedicina; conflictos de interés; industria farmacéutica; políticas editoriales; revistas clínicas.
Conflict of interest disclosure policies in clinically oriented Spanish biomedical journals
Abstract: Professional and financial ties between the pharmaceutical industry and persons and institutions carrying out research, conducting medical training, and practicing medicine can lead to individual or corporate interests influencing decision-making and professional judgment. These conflicts of interest threaten the integrity of research, the objectivity of medical education, the quality of patient care and, more generally, public confidence in medicine. A strategy to protect research integrity and maintain public trust is for authors to communicate their possible conflicts of interest in the studies they publish. This paper analyses the editorial policies of the 16 clinically oriented biomedical journals published in Spain that were included in the JCR in 2011, in relation to authors' conflict of interest declarations. Results show that, in their instructions to authors, most journals mention the need to disclose possible conflicts of interest and offer some sort of description of such situations. However, the definitions are lax concerning which economic relations should be declared and do not specify the extent of personal relationships. In most cases there is no standard form for declaring conflicts of interest; there is no indication of the period of time during which a relationship can be considered likely to generate a conflict; there is no indication of who will evaluate these statements and how they will be evaluated; and there is no indication as to whether these statements will be published in the articles.
Available from: Sally Bell-Syer
- "Previous research in other areas of medicine suggests that funding can have an important impact on a number of trial characteristics. For example, studies have observed that industry-funded drug trials are more likely to report in favour of (the sponsored) treatment when compared with research not funded by a commercial organisation [21-24]. Studies have also shown commercial funding to be associated with shorter duration of follow-up,  more frequent use of non-active comparators [26,27] and a tendency to be at a lower risk of bias [24,28-30]. "
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ABSTRACT: Critical commentaries suggest that wound care randomised controlled trials (RCTs) are often poorly reported with many methodological flaws. Furthermore, interventions in chronic wounds, rather than being drugs, are often medical devices for which there are no requirements for RCTs to bring products to market. RCTs in wounds trials therefore potentially represent a form of marketing. This study presents a methodological overview of complex wound trials published between 2004 and 2011 and investigates the influence of industry funding on methodological quality.
A systematic search for RCTs for the treatment of complex wounds published in the English language between 2004 and 2011 (inclusive) in the Cochrane Wounds Group Specialised Register of Trials was carried out.Data were extracted on aspects of trial design, conduct and quality including sample size, duration of follow-up, specification of a primary outcome, use of surrogate outcomes, and risks of bias. In addition, the prevalence of industry funding was assessed and its influence on the above aspects of trial design, conduct and quality was assessed.
A total of 167 RCTs met our inclusion criteria. We found complex wound trials often have short durations of follow-up (median 12 weeks), small sample sizes (median 63), fail to define a primary outcome in 41% of cases, and those that do define a primary outcome, use surrogate measures of healing in 40% of cases. Only 40% of trials used appropriate methods of randomisation, 25% concealed allocation and 34% blinded outcome assessors. Of the included trials, 41% were wholly or partially funded by industry, 33% declared non-commercial funding and 26% did not report a funding source. Industry funding was not statistically significantly associated with any measure of methodological quality, though this analysis was probably underpowered.
This overview confirms concerns raised about the methodological quality of RCTs in wound care and illustrates that greater efforts must be made to follow international standards for conducting and reporting RCTs. There is currently minimal evidence of an influence of industry funding on methodological quality although analyses had limited power and funding source was not reported for a quarter of studies.
Available from: link.springer.com
- "However, this introduces the potential for bias in model construction and interpretation of the results. In a retrospective analysis of 107 trials in five leading medical journals with regard to outcome and sources of funding, studies sponsored by pharmaceutical companies were much less likely to favor traditional therapy over new drug treatment [60,61]. It is not surprising that new agents are incrementally efficacious; this is the nature of progress in medicine. "
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Despite evidence-based guidelines for venous thromboembolism prevention, substantial variability is found in practice. Many economic evaluations of new drugs for thromboembolism prevention do not occur prospectively with efficacy studies and are sponsored by the manufacturers, raising the possibility of bias. We performed a systematic review of economic analyses of venous thromboembolism prevention in hospitalized patients to inform clinicians and policy makers about cost-effectiveness and the potential influence of sponsorship.
We searched MEDLINE, EMBASE, Cochrane Databases, ACP Journal Club, and Database of Abstracts of Reviews of Effects, from 1946 to September 2011. We extracted data on study characteristics, quality, costs, and efficacy.
From 5,180 identified studies, 39 met eligibility and quality criteria. Each addressed pharmacologic prevention: low-molecular-weight heparins versus placebo (five), unfractionated heparin (12), warfarin (eight), one or another agents (five); fondaparinux versus enoxaparin (11); and rivaroxaban and dabigatran versus enoxaparin (two). Low-molecular-weight heparins were most economically attractive among most medical and surgical patients, whereas fondaparinux was favored for orthopedic patients. Fondaparinux was associated with increased bleeding events. Newer agents rivaroxaban and dabigatran may offer additional value. Of all economic evaluations, 64% were supported by manufacturers of a "new" agent. The new agent had a favorable outcome in 38 (97.4%) of 39 evaluations [95% confidence interval [CI] (86.5 to 99.9)]. Among studies supported by a pharmaceutical company, the sponsored medication was economically attractive in 24 (96.0%) of 25 [95% CI, 80.0 to 99.9)]. We could not detect a consistent bias in outcome based on sponsorship; however, only a minority of studies were unsponsored.
Low-molecular-weight heparins and fondaparinux are the most economically attractive drugs for venous thromboembolism prevention in hospitalized patients. Approximately two thirds of evaluations were supported by the manufacturer of the new agent; such drugs were likely to be reported as economically favorable.
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