The association between funding by commercial interests and study outcome in randomized controlled drug trials
ABSTRACT 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.
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ABSTRACT: Despite increasing awareness about the potential impact of financial conflicts of interest on biomedical research, no comprehensive synthesis of the body of evidence relating to financial conflicts of interest has been performed. To review original, quantitative studies on the extent, impact, and management of financial conflicts of interest in biomedical research. Studies were identified by searching MEDLINE (January 1980-October 2002), the Web of Science citation database, references of articles, letters, commentaries, editorials, and books and by contacting experts. All English-language studies containing original, quantitative data on financial relationships among industry, scientific investigators, and academic institutions were included. A total of 1664 citations were screened, 144 potentially eligible full articles were retrieved, and 37 studies met our inclusion criteria. One investigator (J.E.B.) extracted data from each of the 37 studies. The main outcomes were the prevalence of specific types of industry relationships, the relation between industry sponsorship and study outcome or investigator behavior, and the process for disclosure, review, and management of financial conflicts of interest. Approximately one fourth of investigators have industry affiliations, and roughly two thirds of academic institutions hold equity in start-ups that sponsor research performed at the same institutions. Eight articles, which together evaluated 1140 original studies, assessed the relation between industry sponsorship and outcome in original research. Aggregating the results of these articles showed a statistically significant association between industry sponsorship and pro-industry conclusions (pooled Mantel-Haenszel odds ratio, 3.60; 95% confidence interval, 2.63-4.91). Industry sponsorship was also associated with restrictions on publication and data sharing. The approach to managing financial conflicts varied substantially across academic institutions and peer-reviewed journals. Financial relationships among industry, scientific investigators, and academic institutions are widespread. Conflicts of interest arising from these ties can influence biomedical research in important ways.JAMA The Journal of the American Medical Association 01/2003; 289(4):454-65. DOI:10.1001/jama.289.4.454 · 30.39 Impact Factor
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ABSTRACT: Resumen: El método de la llamada Medicina Basada en la Evidencia (MBE), se ha convertido en los últimos diez años en el paradigma de investigación clínica en las Ciencias de la Salud. Basada en métodos epidemiológicos y estadísticos, con antecedentes en la agronomía y emparentada filosóficamente con el método hipotetico-deductivo, la MBE sé esta estableciendo como la única doctrina que valide el trabajo científico de los profesionales, despreciando los paradigmas científicos que dieron como resultado los avances sensacionales que la medicina ha experimentado en nuestra generación. Entendemos que la MBE debe suponer una ayuda para a que el fruto de la experiencia se concrete en lo posible de manera sistematica y objetiva en recomendaciones prácticas, no que una conclusión genérica, obtenida de un grupo de pacientes, se convierta en una recomendación de actuación específica sobre un enfermo en concreto. Abstract: The method of the "so called" Evidence Based Medicine (EBM), ha become in the last ten years in the paradigm of the clinical investigation in Health Sciences. Based on epidemiologic and statistic methods, with antecedents in agronomy and phylosophically linked with the hypothetic-deductive method, the EBM is being stablished as the unique doctrin that vallidates the scientigic work of these professionals, mis Reading the Scientifi paradigms that resulted the great advances that the Medicine han experienced in ou generation. We feel that the EBM must be a help por the experience to concrete in a systematic and objetive way in practical recommedations, not a gneric conclusion, obtained from a group of patients, will become a specific actuation recommedation of a patient.Revista Espanola de Cirugia Oral y Maxilofacial 01/2003; DOI:10.4321/S1130-05582003000500004
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ABSTRACT: This article describes the current state of the regulation of financial conflicts of interest in research in the United States. It notes the implications of the changing academic and private research environment and reviews recent empirical research on (1) the perceived implications of such conflicts on clinician and researcher behavior, and (2) the effect of disclosure of such conflicts to potential research participants. The article also details a number of widely publicized research “scandals” involving conflicts of interest and the effects these may have on both public support for research as well as on the quality of care that ultimately is delivered. The article then discusses current U.S. federal regulations and initiatives by institutions and professional organizations to further guide researchers and describes how conflicts of interest are typically managed by institutions. It also presents a taxonomy of researcher reactions to efforts by institutional conflict of interest committees to regulate these conflicts. It notes critiques by the Office of the Inspector General of the U.S. Department of Health and Human Services (OIG) of the government's role in the current interplay between government agencies, research sponsors, and institutions in regulating conflicts. Concluding that current efforts to regulate conflicts are inadequate, the article sets forth a proposal for reform of the way conflicts of interest are managed at both the federal and institutional levels.