Publication bias in clinical research sponsored by pharmaceutical industry

An increasing number of clinical trials are funded by the pharmaceutical industry, and the industry as strong commercial interests in research publications that present their products positively and enhance their sales. As main sponsor of clinical trials, the pharmaceutical industry has gained unprecedented control over the evaluation of its own products and communication of research results. There is mounting evidence that industry-sponsored trials are biased in favor of the sponsor’s products. Various potential ways have been described in which pharmaceutical concerns exert influence on the outcome of a study and its communication, however, publication bias proved to be a major cause for bias in industry-funded trials. Pharmaceutical industry and its sponsored investigators selectively report favorable outcomes, fail to publish whole studies with unfavorable results, or publish studies with favorable results multiple times. Such manipulation of research communication might greatly jeopardize the scientific basis for good clinical practice. This article explores the aspects of clinical trial performance that can be affected by pharmaceutical company sponsorship, particularly emphasizing on results dissemination and publication. It is aimed at describing the relationship between pharmaceutical industry sponsorship and bias in research publication. By revealing the scope of the problem and its essence - it attempts to sensitize the scientific, professional and publishing societies and provoke

[1]  Marcia Angell,et al.  Industry-sponsored clinical research: a broken system. , 2008, JAMA.

[2]  P. Easterbrook,et al.  Publication bias in clinical research , 1991, The Lancet.

[3]  P. Rochon,et al.  A study of manufacturer-supported trials of nonsteroidal anti-inflammatory drugs in the treatment of arthritis. , 1994, Archives of internal medicine.

[4]  W. Becker-Brüser [Research in the pharmaceutical industry cannot be objective]. , 2010, Zeitschrift fur Evidenz, Fortbildung und Qualitat im Gesundheitswesen.

[5]  F. Song,et al.  Dissemination and publication of research findings: an updated review of related biases. , 2010, Health technology assessment.

[6]  Paul M Ridker,et al.  Reported outcomes in major cardiovascular clinical trials funded by for-profit and not-for-profit organizations: 2000-2005. , 2006, JAMA.

[7]  B. Beermann,et al.  Evidence b(i)ased medicine—selective reporting from studies sponsored by pharmaceutical industry: review of studies in new drug applications , 2003, BMJ : British Medical Journal.

[8]  Ben Goldacre,et al.  Bad Pharma: How Drug Companies Mislead Doctors and Harm Patients , 2012 .

[9]  J. Ellison,et al.  Good publication practice for communicating company sponsored medical research: the GPP2 guidelines , 2009, BMJ : British Medical Journal.

[10]  R. Simes,et al.  Publication bias: evidence of delayed publication in a cohort study of clinical research projects , 1997, BMJ.

[11]  Christian Gluud,et al.  Association of funding and conclusions in randomized drug trials: a reflection of treatment effect or adverse events? , 2003, JAMA.

[12]  S. Sismondo How Pharmaceutical Industry Funding Affects Trial Outcomes: Causal Structures and Responses , 2008, Social science & medicine.

[13]  Publication of sponsored symposiums in medical journals. , 1993, The New England journal of medicine.

[14]  R. Horton,et al.  Sponsorship, authorship, and accountability. , 2001, Obstetrics and gynecology.

[15]  W. Ludwig,et al.  The financing of drug trials by pharmaceutical companies and its consequences. Part 1: a qualitative, systematic review of the literature on possible influences on the findings, protocols, and quality of drug trials. , 2010, Deutsches Arzteblatt international.

[16]  L. Bero Industry sponsorship and research outcome: a Cochrane review. , 2013, JAMA internal medicine.

[17]  W. Ludwig,et al.  The financing of drug trials by pharmaceutical companies and its consequences: part 2: a qualitative, systematic review of the literature on possible influences on authorship, access to trial data, and trial registration and publication. , 2010, Deutsches Arzteblatt international.

[18]  J. Ioannidis,et al.  Industry sponsorship and selection of comparators in randomized clinical trials , 2010, European journal of clinical investigation.

[19]  D. Rennie,et al.  Influences on the Quality of Published Drug Studies , 1996, International Journal of Technology Assessment in Health Care.

[20]  J. Lexchin Sponsorship bias in clinical research. , 2012, The International journal of risk & safety in medicine.

[21]  S. Golder,et al.  Is there evidence for biased reporting of published adverse effects data in pharmaceutical industry-funded studies? , 2008, British journal of clinical pharmacology.

[22]  H. Kölsch,et al.  Reporting bias in medical research - a narrative review , 2010, Trials.

[23]  Megan M. Filkowski,et al.  Publication bias and the pharmaceutical industry: the case of lamotrigine in bipolar disorder. , 2008, Medscape journal of medicine.

[24]  Alex J. Sutton,et al.  Publication and related biases: a review , 2000 .

[25]  C. Gross,et al.  Scope and impact of financial conflicts of interest in biomedical research: a systematic review. , 2003, JAMA.

[26]  B. Djulbegovic,et al.  Pharmaceutical industry sponsorship and research outcome and quality: systematic review , 2003, BMJ : British Medical Journal.

[27]  Sergio Sismondo,et al.  Pharmaceutical company funding and its consequences: a qualitative systematic review. , 2008, Contemporary clinical trials.

[28]  D. Rennie,et al.  The publication of sponsored symposiums in medical journals. , 1992, The New England journal of medicine.

[29]  W. Ludwig,et al.  [The relation between publication bias and clinical trials funding]. , 2010, Zeitschrift fur Evidenz, Fortbildung und Qualitat im Gesundheitswesen.