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In an extraordinary move, the International Committee of Medical Journal Editors last week issued a proposal to require researchers to share their clinical trial data as a condition for publication. And the researchers would also have to submit plans for how their data can be shared. The journal editors, who represent such periodicals as The New England Journal of Medicine and the Annals of Internal Medicine, believe data sharing “will help to fulfill our moral obligation to study participants, and we believe it will benefit patients, investigators, sponsors, and society.” The move comes after protracted tussling over access due to safety scandals that revealed trial data for some products was never fully published or disclosed. We spoke with Harlan Krumholz, who runs the Yale Open Data Access project and works with companies to publish trial data, about the implications.

Pharmalot: Why does this matter?

Krumholz: People are conducting experiments all the time, and they are funded by various sources, but they are not sharing results. And by not sharing their data, they are biasing the medical literature. Someone goes to the literature and seeks to understand what they are researching, but they’re only seeing a fraction of the studies conducted. So the ability to gain a larger understanding is compromised. We and others have studied this problem and expressed concern, but it has persisted. Nothing was really changing.


We need to create a way so it’s easy for people to share and they get academic credit through crowdsharing of knowledge. Remember that the highest form of scientific productivity is producing information that others use. You know, with the Human Genome Project, they decided to share the information with the world. But with clinical trials, somehow that spirit never took hold.

Pharmalot: So how big a step is it for these journal editors to issue such a statement?


Krumholz: It’s enormous. It means [data sharing] is now a requirement for publication. Previously, there was a lot of support for open science, and some journals tried to make it a requirement, but people could still avoid it. By making a unifying statement, though, it’s a game changer. They will transform the landscape by requiring researchers to disclose study endpoints and their aims. These constitute almost all of the top journals, where people want to publish their work. The editors are flexing their power for the good of science. It’s a remarkable turning point.

Pharmalot: Why do you think it took this long to take this step?

Krumholz: Most researchers want to publish in large journals and disseminate their findings, and there are several reasons. They want to make a contribution to our understanding of science and they want to be recognized for their work. It’s all part of building a career. But there’s no consequence for those who do not share their data.

And it’s easy for investigators who do not want to share to stay on that path. It costs money to prepare a trial for data sharing. Some don’t want to do so because it exposes their underlying work to scrutiny. Some worry that other researchers will build on their work and take advantage of the data that they’ve created but not provide the credit that should accrue back to them.

So it was a cultural norm. There really has been a general expectation that the data was yours to do whatever you wanted with.

Pharmalot: Of course, a researcher may not follow through and share data even after submitting a plan, which raises a question about enforcing the requirement.

Krumholz: They are not going to take down the paper. All these details have yet to be addressed.

Pharmalot: What do you make, though, of the editors at The New England Journal of Medicine? In a recent editorial, they expressed reservations and set off a ruckus by saying that some researchers worry about ‘research parasites.’

Krumholz: There are lot of people who feel the research they do is the best research. It comes across as self-serving and absurd. Science is about replicating and testing your work. We need scientists to test and investigate and provide new insights. … Remember, people may make errors and the only way to catch mistakes and make corrections is to see the data.

To call people parasites who are taking advantage of existing data and using that to generate new knowledge is not parasitism. That’s synergy and building on work of others. … Anyone who holds that view is not seeing the big picture about how different people can work in different ways to help society advance.

I interpret the remark as raising points they’ve heard from others. As one of the most powerful journals in the world, they could have blocked this effort. They should be congratulated. It’s more important they signed on. The big picture is they’re part of this and are behind it. So it’s very positive.

Pharmalot: How much push back do you anticipate from industry?

Krumholz: When I first got into this issue, I wondered whether pharmaceutical companies were the chief offenders, but I think it’s the academics. Companies may push back when they believe they’ve got trade secrets with products that have yet to be approved. But it’s the journal editors who have provided a way to delay sharing data.

I think industry is far ahead of academia. We’re working with Johnson & Johnson, for instance, on opening up their data. So companies are starting to understand that by sharing data, the sky doesn’t fall, science is promoted and reputations are actually improved.