Spinning Clinical Trials

Results of breast cancer drug trials are regularly spun to conceal bias and make the drugs seem more effective or less toxic than they really are.

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WIKIMEDIA, TOM VARCOReports from clinical trials for breast cancer drugs are often rife with bias and spin, according to a study published this week (January 9) in Annals of Oncology.

Researchers from the University of Toronto analyzed the publications from 164 randomized Phase III clinical trials and found that a third were reported positively despite not meeting the primary objective, by emphasizing other, less important outcomes. “These reports were biased and used spin in attempts to conceal that bias,” the authors wrote. Some studies even changed the primary objective halfway through, possibly because early results suggested the trial would otherwise fail.

The researchers also found evidence of bias in the reporting of toxic side effects in two-thirds of the trials, particularly in trials that found the treatment was effective for its primary objective. In these cases, high toxicity findings were omitted from the abstracts and conclusions, and instead buried in the “small print” of the ...

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