he editor of one of the nation’s top medical journals called Tuesday for a “culture change” in the scientific community about clinical trials: Instead of solely glorifying researchers who author papers, scientists should also bestow reverence upon those who generate high-quality data sets for others to analyze.
Dr. Jeffrey Drazen, editor-in-chief of the New England Journal of Medicine, said this was one of the main takeaways of a two-day summit, held Monday and Tuesday in Boston, which attracted 140 patients, data scientists, and researchers who conduct clinical trials. Thousands followed along via an online livestream.
The question of the day: What’s the right balance to strike between sharing data from those trials and keeping them private? The former might speed treatments and help patients. But some scientists have expressed some reticence to immediately share all their data, worrying that competitors will beat them to the punch of analyzing it.
NEJM has found itself in hot water before on this issue, when an editorial coauthored by Drazen raised the possibility of “research parasites” who don’t put in the work to do studies, but just leech off others’ data. Drazen later clarified that he was describing the concerns of other researchers who conduct clinical trials
The Boston event brought out a diverse set of opinions.
Researchers wanted to make sure their data was being used responsibly, including that credit was given to its originators. They noted that sharing data costs money — and a blanket requirement to upload data could well result in a bunch of data sets that wouldn’t be used.
“It is going to come at a financial cost, and if the financial cost is not worth the benefit for all trials, we should invest that time, money, and energy into doing more clinical trials,” said PJ Devereaux, a professor at McMaster University who has run clinical trials. He supported making data from big, important clinical trials available, but questioned whether it was worth it for every study.
Others pointed out that if the data behind a scientific paper is shared, then other researchers can examine it and verify or disprove the conclusions.
This has happened before outside of the medical field, said Margaret Levenstein, who directs a University of Michigan center that hosts an archive for social science data. She pointed to the example of a University of California, Berkeley, graduate student being able to uncover that a Science paper was based on falsified data because those data were stored in her archive.
“The only way we ever knew there was a problem with the data was there were standards in which he was expected to share the data,” Levenstein said.
Patients, meanwhile, appeared baffled at the squabbling scientists.
“When I came here, I had no idea there was any controversy about sharing the data,” said Moses Taylor, who spoke on a patients’ panel Tuesday, and was also a participant in a National Institutes of Health-funded trial on blood pressure treatment. “I also did not realize that people that start these trials and carry them through, the only way they get recognized is publications and that publications determine their career.”
Moses said that it’s up for the scientists in the room to figure out a way to make the data available. The patients agreed that the data should be shared: early, often, and responsibly.
One of the challenges to sharing data is that fame and fortune is often won in the scientific community for publishing papers in journals like Drazen’s, not for producing data sets that might get stored away in a database somewhere.
“We need to come up with better ways to give academic credit to people that generate data sets that lead to lots of important ideas and are used by lots of important people,” Drazen said in an interview with STAT after the summit.
“We think it’s going to require a culture change, we think it’s going to be a beneficial culture change, but [NEJM] can’t be the agents of that change,” Drazen said. He pointed to the role of medical school deans and promotion committees in recognizing data generation the same way they do publication for career decisions like hiring, promotion and tenure.
But journals can do something — the International Committee of Medical Journal Editors, which includes Drazen, proposed in January 2016 that in order for clinical trial papers to be considered for publication in their journals, the authors must commit to sharing the data behind their analyses within at least six months. The proposal has not yet been adopted; Drazen said that it is being workshopped, and that there should be a new version this spring or summer.
Drazen also acknowledged that making data publicly available has benefits beyond enabling scientists to do better research: It increases scientists’ transparency.
“In this time, in this day and age, there’s a concern about what is the truth,” Drazen said during his concluding remarks at the summit. “And I think that having data out there in the public, even if it’s not re-analyzed by lots of people … makes it more believable than if you say, ‘Trust me, I’m a doctor.’”