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Breast Cancer Trial Bias, Or Human Nature?

January 15, 2013
Written by: , Filed in: Breast Imaging, Medical Ethics
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So, apparently, when a clinical trial for a breast cancer treatment doesn’t turn out as well as the researchers had hoped, they sometimes play down the disappointing aspects of the results and emphasize any positive secondary findings they can dredge up.

Imagine that.

Researchers at the University of Toronto and its affiliated Princess Margaret Cancer Centre looked at 164 large, randomized clinical trials of breast cancer therapies published during the period from January 1995 through August 2011. They found that 54 of the trials (33 percent) were reported as positive despite having found no statistically significant benefit relating to the primary end point—the main goal for the therapy in question. The positive spin was based on positive secondary outcomes.

The researchers also said that 110 of the trials (67 percent) played down adverse side effects. “Where trials showed a positive outcome, the toxicities were less likely to be reported,” said Francisco Vera-Badillo, a clinical research fellow at the Princess Margaret. He continued:

A possible explanation for this could be that the investigators, sponsors, or both prefer to focus on the efficacy of the experimental treatment and downplay toxicity to make the results look more attractive.

You think? Vera-Badillo is lead author of an article about trials evaluation. It was published (with open access) last week in Annals of Oncology. Vera-Badillo was quoted in an Oxford University Press news release.

The Toronto researchers found that 103 of the trials (63 percent) received industry funding, but the study found that such funding was not related to the amount of bias in the reporting of outcomes.

The Annals of Oncology article sternly concludes, “Clinicians, reviewers, journal editors and regulators should apply a critical eye to trial reports and be wary of the possibility of biased reporting.”

Well, yeah. But is it really a surprise that, after months of work on a study that might determine a researcher’s academic or professional future, there might be a tendency to seize on any positive results and soft-pedal the less-impressive findings? Anybody who fails to read clinical trial reports—or any other works of (supposed) nonfiction—with a skeptical eye doesn’t know much about human nature.

Related seminar: Breast Imaging and Intervention: A Comprehensive Review (discount and free domestic shipping)

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