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: There is a large and consistent body of evidence showing that research sponsored by for-profit industries tends to have pro-industry conclusions in comparison with similar research or re-analyses not funded by industry. Disclosure of financial conflicts via statements is presently the standard method for notification of potential biases. However, many journals are not consistent in publishing financial conflicts of interest (FCoI) statements. Furthermore, even when divulged, disclosure merely shifts the burden of evaluating conflicts to readers and the general public. Moreover, there has been an absence of a means of quantifying FCoI. To propose a solution for the question: What are we doing about FCoI that continue to compromise the integrity of the scientific enterprise? The FCoI Scale was developed for scoring and comparing FCoI and describing potential biases. The FCoI Scale consists of a score that may be expressed in whole numbers and decimal fractions, correlated to descriptive terms for potential biases and examples of financial conflicts at 11 levels. The FCoI score (FCoIS) provides a means for a more uniform and concise method of disclosure compared to statements, while at the same time permitting flexibility. It encourages the disclosure of relevant information and transparency in the reporting of financial conflicts. The FCoI Scale has the potential to become the standard basis for measuring, reporting, and comparing financial conflicts, suitable for disciplines in science, medicine, and beyond.International journal of occupational and environmental health 01/2015; 21(1):49-52. DOI:10.1179/2049396714Y.0000000097 · 1.10 Impact Factor
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ABSTRACT: Biomarkers are of increasing interest in dementia research. Studies describing favourable accuracy of various dementia tests have influenced research, guidelines and diagnostic criteria. Publication bias is known to compromise reports on efficacy of therapeutic interventions. Traditional methods of quantifying publication bias are not suited to reviews of diagnostic tests. We aimed to describe rates and predictors of publication of dementia test accuracy studies presented at scientific meetings. We chose three exemplar scientific meetings from 2009. Two independent researchers assessed conference proceedings and selected all abstracts relating to dementia diagnostics. We recorded basic descriptors and dichotomised results as 'positive' or 'neutral'. We assessed publication status using electronic literature databases and contacting lead authors. We described univariate and multivariate predictors of publication status using logistic regression modelling. From n = 2257 abstracts, we identified n = 250 (11%) abstracts relating to dementia diagnostics. The majority n = 209 (84%) reported positive results. Only 97 (39%) of these studies are published. Univariate predictors of publication status included positive result (p = 0.042), North American or European authors (p = 0.047), higher number of participants (p = 0.008) and use of a 'biomarker' test (p = 0.035). On multivariate analysis, only increasing number of participants was independently associated with publication (p = 0.034). Our strategy did not prove or disprove a publication bias effect in dementia test accuracy studies. The substantial proportion of 'positive' studies may point to a downstream 'submission bias' effect on decision to submit data to meetings. Modest rate of publication of dementia test accuracy studies is concerning, and publication bias remains possible. Copyright © 2015 John Wiley & Sons, Ltd. Copyright © 2015 John Wiley & Sons, Ltd.International Journal of Geriatric Psychiatry 03/2015; DOI:10.1002/gps.4283 · 3.09 Impact Factor