Medical Journal Editors Back Off Ambitious Data-Sharing Mandate for Publication
Acknowledging the “substantial” hurdles, the International Committee of Medical Journal Editors settles on voluntary sharing—for now.
The International Committee of Medical Journal Editors (ICMJE) has backed off plans to mandate sharing of clinical trial data as a prerequisite for publication, at least for the time being. In an editorial simultaneously published in 13 journals earlier this week, Darren Taichman, MD, PhD, executive deputy editor of the Annals of Internal Medicine, along with other journal editors appeared to express disappointment that their bold vision has not—yet—come to pass.
“Over the past year . . . we have learnt that the challenges are substantial and the requisite mechanisms are not in place to mandate universal data sharing at this time,” they state. “Although many issues must be addressed for data sharing to become the norm, we remain committed to this goal.”
As previously reported by TCTMD, the original proposal, published in 18 international medical journals, called for de-identified patient-level data to be made public according to an agreed upon plan within 6 months of the publication of each trial’s main results. The plan for data sharing would also be a component of clinical trial registration.
The full proposal, however, drew a barrage of comments, some supportive but many others voicing concerns for patient privacy, logistics, the cost of adhering to the ICMJE’s requests, and the fostering of so-called “data parasites.”
“Some applauded the proposals,” Taichman et al write in their editorial published June 6, 2017, “while others expressed disappointment that they did not more quickly create a commitment to data sharing. Many raised valid concerns regarding the feasibility of the proposed requirements, the necessary resources, the real or perceived risks to trial participants, and the need to protect the interests of patients and researchers.”
As such, the revised requirements state only that reports from clinical trials submitted to ICMJE member journals contain “a data-sharing statement,” effective January 1, 2018. For trials that begin enrolling patients on or after January 1, 2019, these must include a data-sharing plan at the time of trial registration on ClinicalTrials.gov or the WHO International Clinical Trials Registry Platform.
Data-sharing statements must include:
- Whether individual de-identified participant data (including data dictionaries) will be shared
- What data in particular will be shared
- Whether additional, related documents will be available (study protocol, statistical analysis plan, etc)
- When the data will become available and for how long
- By what access criteria data will be shared (including with whom, for what types of analyses, and by what mechanism)
The requirements are not mandatary—for now—“but investigators should be aware that editors may take into consideration data-sharing statements when making editorial decisions,” Taichman et al write.
“We envision a global research community in which sharing de-identified data becomes the norm,” they conclude. “Working towards this vision will help maximize the knowledge gained from the efforts and sacrifices of clinical trial participants.”
More Mixed Reactions
Gregg Stone, MD (Columbia University Medical Center, New York, NY), commenting on the editorial for TCTMD, said: "The current ICMJE statement is a very reasonable step forward that advances progress towards data sharing and transparency by requiring all stakeholders to strongly consider this issue for all research studies prior to contemplated publication in many of the leading journals. [By] promoting data sharing and collaboration while allowing flexibility, including the alternative not to publicly share data at this time, the present policy respects valid concerns that have been expressed and that must be worked out prior to this concept becoming universal.”
These include “issues of data housing, researcher qualifications, project scope, application and approval process, database and analysis complexity, patient identity control, authorship, costs and much more,” Stone continued. “The insights gained from what transpires after this first step will no doubt lead to additional discourse on this important topic, and future refinements."
Reaction on Twitter, however, was less supportive of what some saw as a watered-down realization of what was initially a bold, forward-looking plan.
Taichman DB, Sahni P, Pinborg A, et al. Data sharing statements for clinical trials: a requirement of the International Committee of Medical Journal Editors. Ann Intern Med. 2017;Epub ahead of print.