S

hould researchers make public all the data they collect when testing drugs and medical devices on patients?

That’s been a hot question in the scientific community for years — and as debate intensified this week, an unlikely voice weighed in on the side of opening data to all: Massachusetts Senator Elizabeth Warren.

“I appreciate that there are many policy, privacy, and practical issues that need to be addressed in order to make data sharing practical and useful for the research community,” Warren wrote in an editorial in the venerable New England Journal of Medicine, “but the stakes are too high to step back in the face of that challenge.”

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Pushing back against her: a consortium of researchers who wrote their own NEJM editorial, arguing that publishing all the clinical trial data too quickly would let outside scientists pick apart — and potentially discredit — their rivals’ work. Earlier in the year, NEJM editor Dr. Jeffrey Drazen raised another concern as well — that making all data public would enable “research parasites” to steal another team’s data for their own purposes, without putting in the hard work of conducting an original study.

The consortium proposed that researchers be allowed to hold on to their data for at least two years, and in larger trials as long as five years. And they suggested that in some cases, the data should perhaps remain private indefinitely.

That view got no love from advocates of open science.

“It’s a massive ass-covering move as far as I can tell,” said Russ Poldrack, a Stanford University psychology professor who leads the Stanford Center for Reproducible Neuroscience.

“It pits someone’s personal motivation to have an exclusive data that they alone can profit from, set against society’s motivation to use these data for the greatest good,” said Dr. Vinay Prasad, an assistant professor of medicine at Oregon Health and Sciences University.

From Copernicus to Einstein and beyond, Prasad noted, every scientific discovery has been built on the findings of other researchers. In his view, opening the raw data for review would allow for quicker fact-checking — and a faster pace of innovation and improvement in patient care.

“The NEJM publishes studies that really do dictate the practice of medicine, and often dictate regulatory approval,” Prasad said. These studies are often sponsored by the drug or device manufacturers — which makes it doubly important that outsiders evaluate the underlying data and identify any flaws, he said.

“Just in the last decade, we’ve seen a number of examples where clinical trials led to the approval of treatments — but adverse events were covered up,” Poldrack said. “The initial analysis of clinical trial data don’t always give us the whole picture, so it’s really critical, when we’re making societal decisions, to give people what they pay for.”

Hoping to forge a compromise, the International Committee of Medical Journal Editors recently put out guidelines suggesting that scientists make public their clinical trial data — stripped of any information that could identify patients — within six months of publishing their first analysis of the data in a major medical journal.

Warren endorsed that proposal, calling it “a significant step forward.”

But in their NEJM editorial, the International Consortium of Investigators for Fairness in Trial Data Sharing argued that scientists should retain exclusive access to their trial data for years, not months, so that they can do additional analyses and publish supplemental papers.

Without that right, the consortium argued, many scientists wouldn’t agree to do the expensive and arduous work of setting up trials and recruiting patients. Or they might delay submitting their first analysis for publication until they had time to examine all their data at their leisure and write up additional findings — which could slow, not speed up, the pace of medical innovation.

The consortium also argued that researchers should be able to charge fellow scientists to access their data.

Those positions were endorsed by more than 280 scientists in 33 countries.

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