Research under wraps

Many clinical trial results aren’t seeing the light of day.

The nation’s major research institutions aren’t sharing as much as they could or should, according to a recent Yale study: faculty are publishing barely a third of their clinical trial results within two years of completing a study.

In a paper published in the British Journal of Medicine, cardiologist Harlan Krumholz ’80—director of Yale–New Haven Hospital’s Center for Outcomes Research and Evaluation—and colleagues from Yale and other major universities described their examination of 4,347 trials across 51 academic institutions over a four-year period. Their analysis showed that only 29 percent of completed clinical trials were published within a two-year time frame.

In addition, only 13 percent of results were reported on—a National Institutes of Health site designed to make information on publicly and privately supported clinical studies public. Posting on this site, Krumholz says, generally can be done in less than an hour. “Not reporting violates the basic tenets of the scientific method—which include disclosing results,” he adds. “This behavior hurts patients, society, and science. It also dishonors the people who gave their consent and bore the risks of participating in the studies.”

While the reporting rate varied among institutions, no academic center published more than 40 percent of completed clinical trials within two years of completion, or reported results for more than 41 percent of its trials. This “systemic” problem, Krumholz says, shows that “academic medicine has fostered a culture in which the sharing of our results is considered discretionary. We have a moral imperative to disseminate what we learn.”

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