Data sharing in clinical research is only at the start of a “transformation,” and more work is needed to ensure it doesn’t continue to lag behind other science-based disciplines when it comes to the practice, Harlan Krumholz, a Yale University researcher, writes in a perspective in the New England Journal of Medicine.
Krumholz points to work being done both by the International Committee of Medical Journal Editors (ICMJE) and Yale to move the needle forward on data sharing by researchers.
For example, the cardiologist writes, ICMJE in April released a proposal to “accelerate the transformation to a culture of open science.” In that proposal, authors would be required to make deidentified data that underlies the results in a report from a clinical trial available to be shared no more than 6 months after the report is published.
One proponent of the proposal, Sen. Elizabeth Warren (D-Mass.), writes in a companion perspective at NEJM that the data sharing requirement “would be a significant step forward in improving the transparency of clinical trials for consumers and the academic medical community.”
Another step forward is the Yale Open Data Access (YODA) Project, Krumholz adds. That data sharing model, created in 2011, “uses a ‘trusted intermediary’ approach, in which an independent partner provides support, accountability, fairness, and transparency,” he says.
However, use of platforms designed to provide access to individual patient data in order to increase transparency of clinical trial data has been limited, according to a research letter published in March in the Journal of the American Medical Association.
The study involved clinical trials available on ClinicalStudyDataRequest.com, YODA and the Supporting Open Access for Researchers initiative. Of the 234 research proposals submitted, 154 were approved and data-sharing agreements completed for only 113.
Regardless, Krumholz says he will continue to urge for the implementation of data-sharing proposals to strengthen medical research and the integrity of the clinical trial system.
Warren does the same in her perspective.
“I urge researchers with concerns about academic credit or a new way of doing things not to lose sight of the bigger picture: transparency and reanalysis of data are core practices of rigorous, peer-reviewed research, and increasing access to data will ultimately strengthen ... these practices,” she writes.