W

hen the editors of the New England Journal of Medicine warned in January that some scientists thought that sharing data would lead to “research parasites” — a subspecies of researchers who gained unearned glory off the backs of their hard-working colleagues — they earned heaps of scorn from the scientific community.

Critics blasted Dan Longo and Jeffrey Drazen, deputy editor and editor-in-chief, respectively, as petty and shortsighted, more concerned with personal gain than the expansion of knowledge. As one reader responded: “When data can be withheld, researchers can have their cake, by hoarding their data, and eat it, too, by claiming public credit.”

The esteemed journal is at it again, however. A new editorial, from a group of more than 280 researchers in more than 30 countries, argued that science is moving too hastily in the direction of open data, a headlong and thoughtless dash that, they predict portentously, will retard progress and jeopardize human health.

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The essay takes aim at a recent proposal by the International Committee of Medical Journal Editors (ICMJE, of which Drazen is a member) to require that data from any randomized controlled trial — the gold standard of clinical studies — be made fully available within six months of publication.

The new editorial said that proposal, in short, stinks: Although researchers who conduct trials would still get initial credit or their work, they might lose the chance to publish secondary papers and other analyses that they — and not others — deserve.

“A key motivation for investigators to conduct RCTs is the ability to publish not only the primary trial report, but also major secondary articles based on the trial data,” the researchers wrote. “The original investigators almost always intend to undertake additional analyses of the data and explore new hypotheses. … Once the investigators who have conducted the trial no longer have exclusive access to the data, they will effectively be competing with people who have not contributed to the substantial efforts and often years of work required to conduct the trial.”

And they warn of large risks and trivial rewards from mandatory sharing. “The current ICMJE proposal therefore risks reducing the incentive for coinvestigators and site investigators to participate in trials. A reduction in the number of investigators willing to recruit patients into a trial or supervise its conduct in a country will compromise the likelihood of successful completion of large trials that address important questions.”

In other words: Data sharing will cripple scientific progress and harm patients. Full stop.

Implicit in this bleak outlook is a rather stunning arrogance. Are we really supposed to believe that only the researchers who generate data are competent to analyze them? That claim becomes harder to swallow when one considers the poor track record of so many studies. Scientists should want scrutiny.

And while the opportunity cost argument is easier to accept, it’s a straw man hung on a specious scaffold. Of course sharing data will carry costs and divert resources from “the actual conduct of trials.” But again, is that necessarily a bad thing? Not when the state of clinical trials is so shaky to begin with — and so many remain unpublished anyway because they don’t have sexy results. Maybe fewer but more rigorous trials are exactly what the doctor ordered.

The consortium’s solution is to mandate a sharing-free period of two years from initial publication of the data, with up to three more years of exclusivity depending on how long it took to conduct the trial. What’s more, they call for end users to bear at least part of the cost of the sharing — which has a bit of a “We’re going to build a wall, and we’re going to make them pay for it” flavor.

The tone of the essay — which is thrown into relief by accompanying essays by Senator Elizabeth Warren (D-Mass.) and two data sharing proponents — resembles a Cato Institute plea for small government. And in fact, two of the coauthors of the editorial, P.J. Devereaux and Salim Yusuf, of McMaster University in Hamilton, Ontario, have played this song before. The pair were among the coauthors of a 2013 commentary in the NEJM which called for tearing down “unnecessary obstacles” to randomized clinical trials.

Among these perceived barriers: a lengthy and expensive approval process for studies; a “one-size-fits-all” approach for trials of low- and high-risk interventions; and overly burdensome guidelines for the safety and rights of trial volunteers. “Unless radical improvements are made to the regulatory environment,” they wrote, “the potential of clinical trials to assess the safety and efficacy of new and existing treatments, and, thereby, to produce substantial improvements in health care will not be fulfilled.”

Here’s a thought: Putting a hold on data is an unnecessary obstacle, too. Apparently, however, for the authors of the new editorial, obstacles that maximize value for the people who got somewhere first — even by relying on study volunteers — are just fine.

And ultimately, those are the people that trials are meant to help.

“Some scientists seem to believe that as the people with a god-like ability to save lives — like mine — they are the focus of the whole enterprise,” said patient activist Dave deBronkart, who blogs as “e-Patient Dave.” deBronkart credits his survival of a bout of metastatic kidney cancer to being able to get into a trial of an experimental therapy. “And I profoundly disagree. I think that attitude, while it’s understandable from our shared past, is moribund.”

We’re all for fairness in science, but this new proposal is only concerned with fairness for one group: researchers. What’s missing is the second, and, arguably, most important group: the public, including the people who’ve taken part in trials. They deserve a system in which the fruits of studies come as quickly as possible.

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  • Most research happens at academic institutions. Most academic institutions are run, at least in part, on public money. I don’t care if Pfizer is funding a trial, PUBLISH THE DATA.
    “And while the opportunity cost argument is easier to accept, it’s a straw man hung on a specious scaffold. Of course sharing data will carry costs and divert resources from “the actual conduct of trials.” But again, is that necessarily a bad thing? Not when the state of clinical trials is so shaky to begin with — and so many remain unpublished anyway because they don’t have sexy results.”
    The authors – all 280 of ’em – are attempting to play hide the salami. The salami in question is pharma money, thumbing the scale on research findings, or hiding the neg-res of the research they fund.
    Shame on you, NEJM. Shame on you.

  • I participate in clinical trials to have a minuscule chance of helping myself (unlikely because most trials fail) but always to help the other people living with disease by GIVING data to help the research community. And now some researchers are saying they won’t share the data that I GAVE. Are these the same members of the research community who are happily recruiting for risky trials that provide no compensation if patients are injured during their research? How would they like to have experimental brain surgery with no safety net? It’s time for patients to rally against a broken system. It’s my data — not yours to with hold. Let me decide. And if you harm me in a clinical trial, it is your responsibility to fix me.

  • I posted this comment on the NEJM article – they say it’ll be moderated live in 24-48 hours. I really do urge people to read Erin Moore’s post.
    _______

    I implore the authors [of the NEJM editorial] to open their hearts and read this post by Erin Moore, author of a cystic fibrosis patient: “Research is hope.”
    http://66roses.blogspot.com/2016/08/research-is-hope.html

    I implore the authors to consider that while their work is important – I myself am alive due in part to a clinical trial in 2007 – the goal of the entire industry is better health for the people who have the problem; it is NOT for the greater glory of the researcher.

    I implore the authors to ask their hearts: how can fairness to the analysts of a problem outweigh fairness to the people whose baby, or mother, or anyone else, is in big trouble?

    I believe researchers should be well compensated for their work, such that they should not depend on subsequent downstream “sales” of the data (because that’s what it is, right? selling it again?) achieved by withholding it from others who need it.

  • Of course research data should accompany a research article. A primary reason for publishing a paper is to invite others to verify or renounce the findings. We’re the findings a result of good science or bad analysis? If a researcher publishes paper based on a flaw in their computer code, then the sooner people know about it, the better. If they are concerned about people taking their research further, then simply release only the data that was used to arrive at the findings. And given that the findings published in the NEJM influence how patients are treated, then the sooner we find out if the research is good or bad, then the sooner doctors will be able to adopt new treatment techniques with confidence.

    I suspect researchers that don’t want to share are hiding more than their data.

    • Perhaps the most depression aspect of their views is the belief that they are actual the sole proprietors of the data generated by a study. The reality is that the role of other stakeholders, including funders and patients who participated in the study, is just as important in generating that data and should be taken into account.

      “Justice delayed is justice denied” is a central maxim in the area of law. A parallel maxim is equally applicable to the delay of release of information generated in clinical trials. And all for the “convenience” of a senior investigator. A well designed and implemented clinical study should be easy to tabulate at its end and will confirm a hypothesis posed in the protocol. The pressure to publish quickly should should be seen as an opportunity to involve less senior investigators in parallel drafting of secondary papers generated by the study so that they are published in a timely manner.

      One encouraging aspect of the effort to dawdle is that relatively few American investigators seem to have signed on to it. Another is that pharma has largely gone along with, and often has led the effort to share clinical data. They realize that it is the only reasonable approach to the exploding volume of information generated by modern “omics.”

      In the end, it comes down to the golden rule; if the investigators do not like the rules requiring data sharing that most major funders are imposing, then they should not take the gold. Let them conduct a study with their own wallets and bodies.

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