As we have previously written, the topic of whether or not researchers should make all the data they collect when testing drugs and medical devices on patients is a hot-button issue. Data sharing is actually starting to become the rule, more than the exception, as it is being mandated by trial sponsors and has been supported by numerous groups (i.e., the Institute of Medicine/National Academy of Medicine, European Medicines Agency, and the International Committee of Medical Journal Editors).
Senator Elizabeth Warren
In August 2016, the debate was once again brought to the surface, as Massachusetts Senator Elizabeth Warren weighed in. Senator Warren wrote an editorial in the New England Journal of Medicine, where she called for opening data to all: “Data sharing has incredible potential to strengthen academic research, the practice of medicine, and the integrity of the clinical trial system.”
She did make sure to note, however, that opening data to all would not be without difficulty, “I appreciate that there are many policy, privacy, and practical issues that need to be addressed in order to make data sharing practical and useful for the research community, but the stakes are too high to step back in the face of that challenge.”
Elizabeth Warren believes recent ICMJE guidelines are a good first step (more on those later), and that “linking data sharing with publication can also help address the patchwork landscape of current regulations related to the sharing of clinical trial data. Because regulatory agencies have different protocols and requirements for sharing data related to the drugs and devices they approve, access to data about a clinical trial often hinges on which agency handles a regulatory submission rather than on the value of these data to consumers and researchers. By requiring data sharing as a condition of publication, journals can help synchronize and expand existing data-sharing practices.”
The International Consortium of Investigators for Fairness in Trial Data Sharing
However, on the same day Senator Warren’s editorial ran, so did an editorial written by The International Consortium of Investigators for Fairness in Trial Data Sharing. The researchers’ editorial argued that publishing all of their clinical trial data too quickly would let outside scientists pick apart (and potentially discredit) their rivals’ work. They proposed that researchers be permitted to hold onto their data for at least two years, and in larger trials, as long as five years. They also suggested that some instances may call for the data to remain private forever.
They argued that without the right to retain exclusive access to their trial data for years (not months), many scientists would not agree to do the expensive and arduous work of setting up trials and recruiting patients. Or, they might delay submitting their first analysis for publication until they had time to examine all their data at their leisure and write up additional finding. Such a move would slow, not speed up, the pace of medical innovation.
The International Committee of Medical Journal Editors
Recently, the ICMJE put out proposed guidelines, expressing their belief in “an ethical obligation to responsibly share data generated by interventional clinical trials because participants have put themselves at risk.”
The proposal is to “require authors to share with others the deidentified individual-patient data (IPD) underlying the results presented in the article … no later than 6 months after publication.” The requirement will go into effect for clinical trials that begin to enroll participants starting one year after the ICMJE adopts its data-sharing requirements, which the ICMJE plans to do after considering feedback received to the proposals.
Elizabeth Warren endorsed that proposal, calling it “a significant step forward.”