As reported, earlier this year, a top medical journal ignited a backlash by referring to “research parasites”, also known as people who did not personally run a clinical trial or collect data but “use another group’s data for their own ends, possibly stealing from the research productivity planned by the data gatherers.” The New England Journal of Medicine quickly backtracked, as we noted, and clarified its support of data sharing.
Four days after jointly submitting the editorial piece with Dan Longo, M.D., Jeffrey Drazen, M.D., stated the Journal’s support and noted it is “committed to data sharing in the setting of clinical trials.” He went on to comment that he believes “there is a moral obligation to the people who volunteer to participate in these trials to ensure that their data are widely and responsibly used” and that “researchers who analyze data collected by others can substantially improve human health.” In the walk back, he concludes by bringing up data sharing through collaboration, signaling that such form of data sharing may be palatable to more than just the “data socialists” who want to take your hard-researched data a mere six months after the publication of your findings.
Now, research published in the Journal of the American Medical Association (JAMA) suggests there are not enough of these so-called data parasites. The study found that although more than 3000 trials are available to investigators through open data platforms, only 15.5% had been requested by a limited number of researchers. Most proposals focused on nonprespecified subgroups or predictors of response rather than validation of study results. The reasons speculated for underutilization of clinical trials data include lack of knowledge about these resources, possibly due to lack of publication of results from proposals, or lack of funding to support analyses.
In an accompanying editorial, the editors of JAMA argue that sharing data has two principle purposes: to verify the original analysis and hypothesis generation. “It has the potential to advance scientific discovery, improve clinical care, and increase knowledge gained from data collected in these trials. As such, data sharing has become an ethical and scientific imperative,” they wrote.
They also outline that researchers intentionally or inadvertently do not always report important findings from their investigations, citing a report involving clinical data. However, offering all possible data available for reexamination and replication of analyses can help ensure that the publications have fidelity to the trial plan. Perhaps more important, they write, are the study participants. The article cites the International Committee of Medical Journal Editor’s position that there is an ethical obligation to responsibly share data generated by interventional clinical trials because participants have put themselves at risk.
Increasing, data sharing is actually being mandated by trial sponsors and has been supported by numerous groups like the Institute of Medicine/National Academy of Medicine, European Medicines Agency, and ICMJE. Journals and funders, they write, must find common ground to ensure data sharing occurs, but note it is easier to call for data sharing than to actually create a system that protects the privacy of patients and is also efficient, effective, and fair to the investigators who collected the data.
The editorial explains that three issues must be addressed for such a system to be successful. First, the shared data must be deidentified for the protection of individual study participants. Second, a system of sharing data must be efficient. Finally, the system must be fair and respect the investment and contributions of the trial investigators.