[Tupelo3]

The ongoing issue of publishing trial results with negative outcomes appears to effect large studies just as much as smaller ones.

A new analysis found that nearly one-third of trials with negative findings, including those involving neurology, are never published in peer-reviewed journals. Neurology trialists offer their perspectives.

These findings aren't particularly surprising: “publication bias” is a longstanding problem in biomedical science. It's well known that studies with negative findings, especially those sponsored by industry, often never see the light of PubMed, the National Library of Medicine database of biomedical abstracts.

But the new analysis adds to this picture by focusing only on large trials involving 500-plus participants. “This hasn't really been done before, and we weren't sure if it would be an issue in really large studies,” said Dr. Jones. “We were hoping that it wouldn't be as big a problem, because in general, these are studies that have been intended to be published all along. They are going to be attractive to journal editors and shouldn't be prohibitively difficult to get published, and they are very important in terms of informing clinical practice. The considerable time and expense involved in running trials of this size suggests that non-publication is a conscious decision by the sponsors.”

Pressure from drug and device manufacturers to withhold negative data about their products is a longstanding problem. Walter Koroshetz, MD, deputy director of the National Institute of Neurological Disorders and Stroke, recalled a stroke trial from more than a decade ago that was particularly controversial. “The investigator stood up at a national meeting to say that he'd been warned by legal professionals that he could not present the data that he had planned to present. And then he sat down. Everyone present was very upset.” (Representatives from pharmaceutical companies and other industry organizations either did not respond to communications from Neurology Today for this story, or declined to comment.)

“I was actually surprised by these numbers for such large trials,” said Merit Cudkowicz, MD, the Julienne Dorn professor of neurology at Harvard Partners at Harvard Medical School, director of the Massachusetts General Hospital Neurological Clinical Research Institute, and a co-director of the Northeast ALS Consortium. “They allowed a five-year window for these results to be published, and it's really not acceptable for trials of this scope not to be published in that period of time. You're asking people to be part of these studies to try to advance science, and if you're not sharing that data, you're not making an effort to do that.”

POTENTIAL SOLUTIONS
“It's my opinion that there's a potential role for institutional review boards [IRBs] to provide more oversight of the dissemination of trial results,” Dr. Jones said. “Right now IRBs generally do a very good job of looking out for trial participant rights before and during the conduct of clinical trials, but they generally aren't involved once trials have been completed. I think you can make the case that making results available really is an ethical issue for trial participants. “

He also pointed to legislation currently bogged down in a Congressional committee, the Trial and Experimental Studies Transparency (TEST) Act. It would expand the 2007 legislation that originally mandated Clinicaltrials.gov, and close some of its loopholes.

All of this feeds into the broader issues of transparency, said Dr. Koroshetz. “We're trying to build a better culture of data sharing, but it's very difficult. For investigators, their data are their careers, their lifeblood, something they can write papers on for a long time. They're suspicious that if they lose control of the data, then someone else will take advantage.”

Finally, something I've been saying for quite some time.

Perhaps patients themselves have the most control over this situation, if they are made aware of it and choose to exercise their power to refuse to participate in trials. “Most people think that, when they participate in a trial, they are serving the common good,” said Dr. Koroshetz. “I think it's worthwhile getting information about trials going unpublished out to the general public. Patients have the power to make a change, by not participating unless they have something in writing guaranteeing that the data are going to be published.”

http://journals.lww.com/neurotodayon...ials_Go.8.aspx

I would love to see some type of organization formed which specifically tracks researchers and their publications, or lack their of. We would grade them on their past results and then get patients to only support trials for those that make their results available and publish.

[Bob Dawson]

At the risk of offending the border guards, and being identified as enemies of the people, we present the following evidence:

http://youtu.be/JKRIoY9aXK8

[dilmar]

At the risk of stating the known here is the all trials published web site.

http://www.alltrials.net