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A group of researchers have thrown down a challenge to sponsors and investigators of “invisible” or abandoned clinical trials to publish the information.
In a June 13th article in the online version of BMJ, lead author Peter Doshi, PhD, of Johns Hopkins School of Medicine call for RIAT (“restoring invisible and abandoned trials”) -- the publishing of invisible or abandoned clinical trials if the data have not been published within a year. Doshi and colleagues define “abandoned” trials as those that are documented as misreported or no longer have sponsors actively seeking publication. “Invisible” trials are those that are completed but remain unpublished. This information should be published, the authors say, “because abandonment can lead to false conclusions about effectiveness and safety, we believe that it should be tackled through independent publication and republication of trials.”
Doshi et al propose these steps for RIAT publishing:
Doshi and colleagues plan to email their article to the major pharma companies to try to convince them to publish the trials. If the companies do not announce an intention to do so, then clinical trial reports will be available for anyone to publish, Doshi says. The companies may not like Doshi’s somewhat hardline stance on the issue, though they may be open to the concept.