Publish or . . . don't

"If trials aren't being published, what is being learned?"

Gregory Nemec

Gregory Nemec

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All would-be medical advances must travel the road of the clinical trial, in which drugs, devices, and procedures are tested on humans. The National Institutes of Health, which spends more than $3 billion a year funding clinical trials, expects the results—good or bad—to be made public, to inform future research and practice.

A new Yale study finds, however, that only 46 percent of NIH-sponsored trials were published within 30 months of completion. Another third remained unpublished 51 months after completion.

"If the trials aren't being published, what is being learned?" asks Joseph S. Ross '06MHS, assistant professor of medicine and lead author of the study, which appeared in the January 3 issue of BMJ. "It's dollars that are wasted."

Using a federal database, Ross's team examined 635 trials completed between 2005 and 2008, checking to see how many had been published in a peer-reviewed journal by July 2011. Only 294 appeared within 30 months. The publication rate was the same regardless of the disease being studied or the NIH funding agency.

Ross had reviewed industry-sponsored trial results for a 2009 study, and saw an even lower publication rate—40 percent. One possible reason for this, Ross says, is that investigators are not publishing unpromising results. But "we were surprised to see government-sponsored trials were not doing much better," he says.

Ross has two theories for this delay: researchers fail to get their work accepted by a journal, or they don't prioritize dissemination of findings. He also thinks they may become so involved in the next project that they neglect to pursue publication of the last one.

The NIH provides research funding to 325,000 investigators at more than 3,000 universities, medical schools, and other research institutions in the United States and worldwide, but it does not require that the results be published.

"The failure of NIH-supported investigators to disseminate their research results in a timely fashion is deeply concerning," the NIH said in a statement responding to Ross's study. The agency said it will examine why this is happening "and identify approaches to assure timely publication."

Ross has his own suggestion: the NIH could withhold the final 10 percent of the grant—and future grants—until the researcher gets the current study published.

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