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Drug Trials Funded by Industry Are More Likely to Publish Favorable Results
Date:8/2/2010

l Link';s.eVar3=s.prop5;s.prop15='99801664';s.tl(this,'o','ExternalLink');" target='_blank' href="http://content.nejm.org/cgi/content/short/358/3/252">The New England Journal of Medicine.

"While we cannot specifically point to which factors contribute to the association between funding source and positive result reporting, our findings speak to the need for more disclosure of all elements of a study," says Bourgeois.  "Publication bias is likely a contributing factor, but there may be many more, including biases in study design, patient selection, data analysis and results reporting."

The use of registries like ClinicalTrials.gov, launched in 1999, was hoped to reduce publication bias by creating a record for all clinical trials. In addition, in 2005, the International Committee of Medical Journal Editors began requiring that a trial be registered before enrolling patients in order to be considered for publication, thus creating a record of the planned study outcomes before the study's initiation. In 2007, the FDA expanded the scope of ClinicalTrials.gov, requiring the sponsors of all drug, biologic and device trials to register their studies upon launch (phase I trials excepted).

If trial protocols are made public in advance, a trial sponsor is less able to manipulate or selectively publish the findings, the researchers argue.  "Our main call is for transparency, to enable better understanding of the impact of funding source on the study outcomes, and for all study results – good or bad – to be made available," says Mandl, the study's senior investigator, also an Associate Professor at Harvard Medical School.

The study was funded by the National Library of Medicine and the National Institute of Child Health and Human Development.

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SOURCE Children's Hospital Boston
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