Abstract

JIMENEZ-COTES, Evert A.; MEJIA-CARDONA, laura  and  DONADO-GOMEZ, Jorge H.. Publication Trend of Clinical Trials with Negative Results Funded by Pharmaceutical industries for the 2007-2012 Period. Rev. Cienc. Salud [online]. 2015, vol.13, n.1, pp.55-62. ISSN 1692-7273.  https://doi.org/10.12804/revsalud13.01.2015.04.

Objective: To evaluate the results of clinical trials financed by the pharmaceutical industries during the period 2007-2012 in a general medical journal. Materials and methods: We performed an observational cross sectional study where originals clinical trials financed by the pharmaceutical industry published between 2007 and 2012 in the journal The New England Journal of Medicine (http://www.nejm.org) were reviewed. Trend χ² test was used to evaluate the results of studies over the years. A database was created with different variables, identifying the number of publications and the period of greater publishing negatives studies, as well as the medical specialty and pharmaceutical industry funding. Results: 321 clinical trials were analyzed. The Odds Ratio was calculated for each year evaluated, finding a χ²of linear trend in negatives studies of 2.91 with value p 0.08 and positive studies of 1.16 with value p 0.28. It was found that in the period 2007-2009 123 studies were published, 40% of which presented negative results; unlike the 2010-2012 period in which 198 clinical trials where published, 142 of them, showed positive results, OR 1.68, 95 % CI (1.02-2.78) value p 0.03. The highest figures of negative results were published in 2007: 44.7 %. Conclusions: A progressive decrease in the number of publications with annual general negative results has been observed. A statistically significant difference in the publication of negative studies per year was not found between the periods 2007-2012. The medical specialty that showed the largest number of total and negative publications in both periods was cardiology. The pharmaceutical industry that sponsored most total clinical trials with negative results in both periods did so through Merck, Glaxo SmithKline, and Sanofi-Aventis. 50 % of neurology publications showed negative results.

Keywords : Clinical trial; Bias; Publication bias; Outcome assessment; Outcome.

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